Summary Report

September 22, 2020 

Atlanta, Georgia 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

Advisory Committee on 

Immunization Practices (ACIP)
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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Table of Contents Page

Agenda 3 

Acronyms 4-6 

Welcome and Introductions 7-8 

Coronavirus Disease 2019 (COVID-19) Vaccines

 Introduction

 Overview of COVID-19 Vaccine Safety

 Enhanced Vaccine Safety Surveillance

 Vaccine Implementation

 Disparities Among COVID-19 Epidemiology

 Overview of Vaccine Equity and Prioritization Frameworks

 Phase 1 Allocation for COVID-19 Vaccine: Work Group Considerations

8-48

Certification 49 

Membership Roster 50-59 
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Agenda
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Acronyms

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACA Affordable Care Act 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

AE Adverse Event

AECI Adverse Events of Clinical Interest 

AESI Adverse Events of Special Interest 

AGS American Geriatric Society 

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

ASPR Assistant Secretary for Preparedness and Response 

ASTHO Association of State and Territorial Health Officers 

ATS American Thoracic Society 

BEST Biologics Effectiveness and Safety 

CDC Centers for Disease Control and Prevention

CEA Cost-Effectiveness Analysis 

CEPI Coalition for Epidemic Preparedness Innovations 

CFR Code of Federal Regulations 

CISA Clinical Immunization Safety Assessment 

CISA Cybersecurity and Infrastructure Security Agency

CKD Chronic Kidney Disease

CMS Center for Medicare and Medicaid Services

COI Conflict of Interest 

COU Clinical Operations Unit 

COVID-19 Coronavirus Disease 2019 

CoVPN COVID-19 Prevention Network 

CVD Cardiovascular Disease

DFO Designated Federal Official

DHA Defense Health Agency 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

EHR Electronic Health Record 

EMS Emergency Medical Services 

ET Eastern Time

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration
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GRADE Grading of Recommendation Assessment, Development and Evaluation 

GSK GlaxoSmithKline 

HAIs Healthcare-Acquired Infections 

HHS (Department of) Health and Human Services

IDCRP Infectious Disease Clinical Research Program 

ICU Intensive Care Unit

IDSA Infectious Disease Society of America 

Ig Immunoglobulin

IHR International Health Regulation

IHS Indian Health Service 

IIS Immunization Information Systems 

JHSPH Johns Hopkins Bloomberg School of Public Health 

LTCF Long-Term Care Facilities 

MedDRA Medical Dictionary for Regulatory Activities 

MMRV Measles, Mumps, Rubella, and Varicella

MMWR Morbidity and Mortality Weekly Report

mRNA Messenger Ribonucleic Acid 

MIS-C Multisystem Inflammatory Syndrome in Children 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAM National Academy of Medicine 

NAPNAP National Association of Pediatric Nurse Practitioners 

NAS National Academy of Sciences 

NASEM or the 

National 

Academies

National Academies of Sciences, Engineering, and Medicine 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

NCHS National Center of Health Statistics 

NCIRD National Center for Immunization and Respiratory Diseases 

NFID National Foundation for Infectious Diseases 

NHIS National Health Interview Survey 

NHSN National Healthcare Safety Network 

NMA National Medical Association 

NYC New York City

OCR Office for Civil Rights 

OWS Operation Warp Speed 

PCR Polymerase Chain Reaction 

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PIDS Pediatric Infectious Disease Society 

PPE Personal Protective Equipment 

RNA Ribonucleic Acid 

SAGE Strategic Advisory Group of Experts on Immunization

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus-2 
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SDOH Social Determinants of Health

SHEA Society for Healthcare Epidemiology of America 

SLU Saint Louis University 

SME Subject Matter Expert

SPEAC Safety Platform for Emergency vACcines 

SVI Social Vulnerability Index 

TA Technical Assistance

US United States

VA (US Department of) Veteran’s Affairs 

VAERD Vaccine-Associated Enhanced Respiratory Disease 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Subgroup 

VE Vaccine Efficacy

VE Vaccine Effectiveness

VRBPAC Vaccines and Related Biological Products Advisory Committee Meeting 

V-SAFE Vaccine Safety Assessment for Essential Workers 

VSD Vaccine Safety Datalink

VTU Vaccine Treatment Evaluation Unit 

WG Work Group

WHO World Health Organization
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Call To Order, Welcome, Overview, Announcements, & Introductions

José Romero, MD, FAA 

ACIP Chair 

Amanda Cohn, MD 

Executive Secretary, ACIP / CDC 

Dr. Cohn called to order the September 22, 2020 meeting of the Advisory Committee on 

Immunization Practices (ACIP), indicating that it was ACIP’s third emergency meeting to 

discuss Coronavirus Disease 2019 (COVID)-19 vaccines. She welcomed everyone participating 

by Zoom or watching via the live webcast. 

She indicated that copies of the slides for this meeting would be available until 5:00 PM Eastern 

Time (ET) on the ACIP website at the following URL: 

https://www.cdc.gov/vaccines/acip/meetings/slides-2020-09.html

Dr. Cohn explained that at the end of the meeting, the slides would be removed from the site, 

made 508-compliant, and returned to the website within approximately 4 weeks of the meeting. 

Additionally, the slides to be presented during this meeting were made available through a 

ShareFile link for ACIP Voting, Liaison, and Ex-Officio members. The live webcast videos will 

be posted approximately 4 weeks following the meeting, and the meeting minutes are posted to 

the ACIP website generally within about 120 days following the meeting. 

In terms of meeting logistics, participants were instructed to raise their hands virtually when Dr. 

Romero opened the floor for discussion and to disable their video or mute their phone lines to 

reduce issues with the Zoom connection. Dr. Cohn explained that during the discussion period, 

the order in which Dr. Romero would take questions would be first from ACIP Voting Members, 

second from Ex Officio and Liaison member representatives, and then from the audience. The 

plan was to stay on schedule with the meeting agenda. If running early, a break would be taken 

until time for the next item on the agenda. 

The next regularly scheduled ACIP meeting also will be virtual. That meeting will be convened 

on October 28-29, 2020. This will once again be a virtual meeting and it is anticipated that the 

agenda for this meeting will cover both COVID-19 vaccines as well as other routine business. 

Dr. Cohn explained that this meeting’s oral and written public comment processes were 

designed to accommodate increased public interest in ACIP’s work, maximize opportunities for 

comments, make public comments more transparent and efficient, and create a fair process for 

assigning limited oral public comment time. For this meeting, one oral public comment period 

would be held in the afternoon beginning at approximately 3:45 PM. Additionally, written public 

comments may be made via regulations.gov using Docket Number ID CDC-2020-0093. 

Information on the written public comment process, including information about how to make a 

public comment, can be found on the ACIP website. 
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As noted in the ACIP Policies and Procedures manual, members of the ACIP agree to forgo 

participation in certain activities related to vaccines during their tenure on the committee. For 

certain other interests that potentially enhance a member’s expertise, CDC has issued limited 

conflict of interest (COI) waivers. Members who conduct vaccine clinical trials or serve on data 

safety monitoring boards (DSMBs) may present to the committee on matters related to those 

vaccines, but are prohibited from participating in committee votes. Regarding other vaccines of 

the concerned company, a member may participate in discussions with the provision that he/she 

abstains on all votes related to that company. At the beginning of each meeting and prior to 

each vote, if any, ACIP members state any COIs. While ACIP members would be stating their 

COIs at the beginning of this meeting, no votes were scheduled that would prohibit members 

who declared COIs from participating in the meeting.

Dr. Romero conducted a roll call of ACIP members, during which the following COIs were 

declared:

 Dr. Robert Atmar is serving as the Co-Director of the Clinical Operations Unit (COU) of the 

National Institutes of Health (NIH)-funded Infectious Diseases Clinical Research Consortium

(IDCRC) that is working within the COVID-19 Prevention Network (CoVPN) to evaluate 

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) vaccine candidates in 

Phase 3 clinical trials, including those produced by Moderna, AstraZeneca, Janssen,

Novavax, and Sanofi. 

 Dr. Sharon Frey is employed by Saint Louis University (SLU). SLU has a Vaccine Treatment 

Evaluation Unit (VTU) that is part of the IDCRC. She is currently working with the CoVPN on 

the Moderna COVID-19 vaccine trials and anticipates working on the Janssen trial and 

others in the future.

 Dr. Paul Hunter owns a small amount of stock in Pfizer and has received a small grant from 

Pfizer to conduct a quality improvement project on pneumococcal vaccines.

 Dr. Pablo Sánchez receives grant support from Merck for research focused on global 

antibiotic use, which is soon ending.

A list of Members, Ex Officio Members, and Liaison Representatives is included in the 

appendixes at the end of the full minutes for the September 2020 ACIP meeting.

Coronavirus Disease 2019 (COVID-19) Vaccines

Introduction

Beth Bell, MD, MPH 

ACIP COVID-19 Vaccines WG Chair

Clinical Professor, Department of Global Health

School of Public Health, University of Washington 

Dr. Bell introduced the session and provided a few brief updates. As a reminder, during the 

August 26, 2020 meeting, ACIP reviewed the following: 
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 Moderna’s mRNA COVID-19 Vaccine Clinical Development

 Pfizer/BioNtech’s mRNA COVID-19 Vaccine Clinical Development 

 Overview of Post-Marketing Safety Surveillance

 Epidemiology of Individuals at Increased Risk of Severe COVID-19 Disease 

 WG Interpretation 

 Prioritization and WG Next Steps

Since that time, the COVID-19 Vaccine WG has been meeting weekly. Topics covered during 

the August WG meetings included the following:

 Review of Published COVID-19 Vaccine Prioritization and Allocation Frameworks

 Qualitative Research on a Future COVID-19 Vaccine

 Clinical Development Program for a COVID-19 Vaccine, Including Data from Phase I/II 

Clinical Trials and Plans for Phase III Clinical Trials

 Racial and Ethnic Disparities in COVID-19 Testing, Exposure, Severity, and Impact

 Association Between Social Vulnerability and Risk of Becoming a COVID-19 Hotspot

 Proposal for Ethics/Equity Framework for COVID-19 Vaccine Allocation

 Further discussions regarding COVID-19 vaccine allocation

Dr. Bell indicated that the agenda for the September 22, 2020 ACIP meeting would include

presentations on the following topics:

 Overview of COVID-19 Vaccine Safety 

 Enhanced Vaccine Safety Surveillance 

 Vaccine Implementation

 Disparities in COVID-19 Epidemiology

 Overview of Vaccine Equity and Prioritization Frameworks

 Phase 1 Allocation for COVID-19 Vaccine: WG Considerations

Regarding considerations for prioritization of COVID-19 vaccines, Dr. Bell noted that two of the 

presentations would be particularly relevant, including disparities among COVID-19 disease and 

a proposal for ACIP’s Ethics & Equity Framework and a review of groups for allocation of initial 

COVID-19 vaccine. Moving forward in future sessions, the WG envisions continuing to discuss 

the Evidence to Recommendation (EtR) Framework for COVID-19 vaccines, review additional 

manufacturer data as they become available, and prepare for independent review of safety and 

efficacy data from Phase III clinical trials.

In terms of the status of vaccines globally, over 200 COVID-19 vaccines are currently under 

development. Within the United States (US), there are two vaccines in Phase III clinical trials 

that are actively enrolling. There is one vaccine in Phase III clinical trials, which is currently on 

hold. There are three vaccines in Phase I/II clinical trials that are actively recruiting. The two 

vaccines in Phase III clinical trials that are actively recruiting are the mRNA-1273 vaccine from 

Moderna and the BNT162b2 vaccine from Pfizer/BioNtech. The Moderna mRNA-1273 Phase III 

trial reported 25,296 participants enrolled as of 9/16/2020, with 28% of the participants enrolled 

being from “diverse communities.” The Pfizer/BioNtech BNT162b2 vaccine trial reported 31,928

participants enrolled as of 9/21/2020, with 26% of participants enrolled having “diverse 

backgrounds.” Pfizer/BioNtech has proposed expansion of its clinical trial to 44,000 participants.
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Additional COVID-19 vaccines in human clinical trials in the US include the University of 

Oxford/AstraZeneca vaccine, which is currently on hold, and three other trials that are currently 

recruiting. These include a non-replicating viral vector vaccine by Janssen Pharmaceutical, a 

protein subunit vaccine by Sanofi/GlaxoSmithKline (GSK), and a protein subunit vaccine by 

Novavax. There also are a number of vaccines in human clinical trials outside of the US that are 

actively recruiting. There are six inactivated candidate vaccines currently recruiting in trials 

throughout the world. There are nine viral vector vaccines, most of which are still in Phase I/II 

trials with the exception of the University of Oxford/AstraZeneca and a vaccine manufactured in 

Russia that are in Phase III trials. There are six protein subunit vaccines in human clinical trials 

outside of the US being studied in Australia, Taiwan, and South Africa. There are three mRNA 

and four DNA vaccines in human clinical trials outside of the US in parts of Europe, South 

Korea, Singapore, Japan, and India.

In terms of the path forward for ACIP to vote on and make COVID-19 vaccine 

recommendations, the WG is meeting weekly as mentioned to review Phase I/II data from 

manufacturers as the data become available and to design the structure for independent data 

review that will occur once Phase III data are available. Once data are available from Phase III 

clinical trials, the ACIP WG will conduct independent reviews of safety and efficacy data using 

the EtR Framework and the Grading of Recommendation Assessment, Development and 

Evaluation (GRADE) system. Based on this data review, the WG will present policy options to 

the full ACIP. The ACIP makes recommendations about Food and Drug Administration (FDA) 

licensed or authorized vaccines. If and when an FDA decision is announced about a particular 

vaccine, the ACIP will convene an emergency meeting with a public comment session. The 

ACIP will review the safety and efficacy data using the GRADE system and the EtR framework. 

The ACIP will then vote on recommendations for the vaccine and the populations for use. 

Notably, the ACIP recommendations could be more targeted or detailed than the FDA 

“Conditions of Use” that accompany licensure. After an ACIP vote, the ACIP submits the 

recommendations to the CDC Director. If those recommendations are accepted, they are 

published in the Morbidity and Mortality Weekly Report (MMWR) and become official CDC 

policy.

Overview of COVID-19 Vaccine Safety

Grace M. Lee, MD MPH

Chair, ACIP COVID-19 Vaccine Safety Technical Subgroup

Associate CMO, Stanford Children’s Health

Professor of Pediatrics, Stanford University School of Medicine

Dr. Lee provided an overview of the COVID-19 vaccine safety activities on behalf of the ACIP 

COVID-19 Vaccine Safety Technical Subgroup (VaST). She emphasized that safety is not the 

absence of risk. Everyone takes risks every day, whether it is getting on a plane to see loved 

ones or going outside for a walk when it is fire season on the west coast. Safety is actually 

about finding an acceptable balance of benefits and risks.

There are two independent advisory committees that review vaccine safety on a regular basis. 

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) provides advice 

to the Commissioner of the FDA. VRBPAC evaluates data concerning the safety, effectiveness, 

and appropriate use of vaccines for which the FDA has regulatory responsibility. ACIP provides 

advice and guidance to the Director of the CDC. ACIP provides recommendations on the use of 
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vaccines in the U.S. civilian population based on disease epidemiology, vaccine safety, vaccine 

efficacy and effectiveness, the quality of the evidence reviewed, economic analyses, and 

implementation issues.

Vaccine safety data are routinely considered by ACIP WGs. The role of ACIP is to deliberate 

about benefit-risk balance and recommendations for use. ACIP is routinely updated on postmarket safety and effectiveness data for vaccines, and modifies those recommendations as 

needed. Decision-making is intended to be a dynamic process as new data and evidence 

emerge. For COVID-19 vaccines, a separate safety group was assembled in June 2020 to 

support the COVID-19 Vaccines WG and the full ACIP on the safety of COVID-19 vaccines in 

development, post-authorization, and post-licensure.

The VaST includes three ACIP members (Lee, Bell, Talbot); seven consultants with expertise in 

coronavirus immunology, clinical trials, vaccine safety, pregnancy, and risk communication 

(Belongia, Daley, Edwards, Kulldorff, Riley, Perlman, and Viswanath); and Ex Officio members 

(CDC, FDA, DoD, VA, IHS, HRSA, HHS, NIH, BARDA). Dr. Lee extended gratitude to the CDC 

Lead, Dr. Tom Shimabukuro, for his leadership of this group.

The terms of reference for VaST that were developed in May 2020 are to serve as the central 

hub for technical subject matter experts (SMEs) to: 1) review and interpret pre-authorization/prelicensure SARS-CoV-2 vaccine candidate safety data; 2) review and interpret postauthorization/post-licensure SARS-CoV-2 vaccine safety data; and 3) provide advice and 

guidance on presenting post-authorization/post-licensure SARS-CoV-2 vaccine safety data to 

the COVID-19 Vaccines WG, the full ACIP, and the general public.

VaST convened its kickoff meeting on June 8, 2020, which was then followed by an overview on 

June 22nd of vaccine-associated enhanced respiratory disease (VAERD) as an outcome; this 

potential adverse event (AE) is important in the selection of vaccine candidates to minimize a 

theoretical risk of VAERD. On July 2nd, VaST had the opportunity to meet with global vaccine 

safety colleagues to discuss potential adverse events of special interest (AESI), a case 

definition in progress for VAERD, and standardized Brighton Collaboration templates. They then 

had four full meetings discussing the capabilities of post-marketing vaccine safety surveillance 

systems for monitoring the safety of COVID-19 vaccines, including the Vaccine Adverse Event 

Reporting System (VAERS), Vaccine Safety Datalink (VSD), Clinical Immunization Safety 

Assessment (CISA), Center for Medicare and Medicaid Services (CMS), FDA, Veteran’s Affairs 

(VA), Department of Defense (DoD), Indian Health Service (IHS), National Healthcare Safety 

Network (NHSN), and Vaccine Safety Assessment for Essential Workers (V-SAFE). VaST also 

recently discussed frameworks for risk communication.

Two key statements have been endorsed by VaST. First, VaST asked its colleagues whether 

safety monitoring for Phase III clinical trials should be harmonized in terms of definitions for 

AESIs and/or duration of follow-up. The group said “yes” that harmonization is critical for timely 

evaluation. It would allow for the combination of data, if appropriate, by maximizing the sample 

size for any given AESIs. It would also allow for the comparison of safety across different 

vaccine platforms and trials, if appropriate, and enable the dynamic assessment of benefit-risk 

balance. The group also felt that harmonizing with international standards, such as the Brighton 

Collaboration, would be preferred. Similar to the FDA guidance on COVID-19 VE that was 

published in the summer, the group felt that FDA guidance is needed on vaccine safety 

standards. The COVID-19 vaccine clinical trials that are in progress or planned are currently 
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proposed to include between 30,000 to 50,000 participants per trial. These trials are designed 

for efficacy, but also can be designed for safety, if sufficient follow-up is allowed. For example, 

rotavirus vaccine trials were specifically designed with safety as a primary endpoint. The 

minimum duration of follow-up needed to assess safety, or the benefit-risk balance, depends 

upon the types of AEs events and the associated risk intervals.

The second question VaST asked of their colleagues pertained to whether safety monitoring for 

post-authorization or post-licensure safety surveillance systems should be harmonized. There 

was general agreement that it is critical for timely evaluation similar to clinical trials. Common 

protocols, outcome definitions, risk windows, and approaches to severity grading can support 

rapid evaluation of statistical signals. However, it is recognized that different systems may have 

different capabilities, such as billing versus electronic health record (EHR) data, to identify 

exposures or outcomes and that systems may need to align rather than fully harmonize in 

certain instances.

The group felt that the capability for timely evaluation of statistical signals is crucial for vaccine 

confidence, and that coordination across post-market safety surveillance systems is 

recommended similar to the experience with H1N1 vaccine safety. As a reminder, near real-time 

safety surveillance systems are designed to optimize sensitivity. Therefore, statistical signals 

should be expected in a robust monitoring program. Two examples include syndromic 

surveillance performed in four states which identified 62 alerts corresponding to 17 distinct 

signals, but only two true clusters of illness were detected. More specifically, in the VSD, Yih 

and colleagues published their experience of monitoring safety for five different vaccines, 

following five to seven AESIs per vaccine. While 10 statistical signals occurred, 9 were spurious; 

only one was a true signal that led to a revised ACIP recommendation for measles, mumps, 

rubella, and varicella (MMRV) vaccine. Timely and thorough investigations of statistical signals 

are needed to distinguish true associations.

VaST adopted the Safety Platform for Emergency vACcines (SPEAC) classification of AESIs. 

SPEAC is a collaboration between the Coalition for Epidemic Preparedness Innovations (CEPI) 

and the Brighton Collaboration. They anticipate bringing prioritizations forward in future 

meetings. General AEs of interest are those typically monitored for vaccines such as 

anaphylaxis. Platform-specific (e.g., mRNA, viral vector, adjuvanted) AESIs of interest will be 

based on the findings from clinical trials. Population-specific AESIs of interest might include 

multisystem inflammatory syndrome in children (MIS-C) in children.

At this point, it is anticipated that there will be a transition in the role of VaST. During the current 

pre-authorization or pre-licensure phase, VaST will remain focused on discussing prioritized 

AESIs; discussing common protocols for enhanced passive and active surveillance; discussing 

approaches to signal refinement and evaluation; and reviewing and refining membership of the 

data review group in the post-authorization or post-licensure phase. Once vaccine candidates 

are licensed or authorized for use, VaST will prospectively review, evaluate, and interpret the 

safety data from ongoing clinical trials in near real-time and from passive, enhanced passive, 

and active surveillance systems. VaST will advise on signal refinement, signal evaluation 

activities, and data presentation to ACIP and the public.
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In order to succeed at this task, VaST highlighted six conditions for success. First, the ability to 

capture vaccine exposure in vaccine safety surveillance systems is needed. Clarity is needed 

not only on the distribution processes and the documentation of vaccines administered, but also 

to ensure that this information can and will be linked to outcome data in systems that are 

planning surveillance of COVID-19 vaccines. Second, the ability to define background rates of 

AESI in the general population and among those with COVID-19 disease is necessary for 

success. This is challenging, but reliance on background rates is important to understand what 

typical rates might look like. COVID-19 has changed the way that patients utilize health 

services, which makes it particularly challenging. Understanding rates among those with 

COVID-19 disease is important because some of the outcomes they hope to monitor are 

actually seen with COVID-19 disease. In order to best assess the benefit-risk balance, it will be 

important to have information on rates following disease as well as post-vaccination. Third, it will 

be necessary to minimize conflicts of interest among members of the data review group. Fourth, 

VaST believes that a learning health system’s approach to vaccine is needed with shared 

review and shared learning across all COVID-19 vaccine safety surveillance systems. Fifth, the 

VaST has requested and been granted the ability for the data review group to discuss findings 

independently. Six, a well-developed communication plan will be needed on safety issues 

throughout the lifecycle of vaccines. Strong collaborations and partnerships will be needed in 

order to meet the needs of ACIP, provider organizations, and the public. 

In closing, systems have been designed to detect safety signals. It is how those signals are 

collectively handled that will define the country’s ability to respond to COVID-19.

Discussion Points

Dr. Fryhofer (AMA) asked whether the Department of Health and Human Services (HHS) 

Secretary also is involved in the process after the CDC recommendations are sent to the CDC 

Director.

Dr. Cohn indicated that CDC would confirm this. Typically, under the Federal Advisory 

Committee Act (FACA), the CDC Director makes the final decision and informs the HHS 

Secretary. 

Dr. Goldman (ACP) stressed the importance of taking safety very seriously to ensure public 

confidence in the process and applauded the COVID-19 Vaccines WG and the VaST in their 

strong work for examining the detailed processes in order to have a safe and effective vaccine.

Dr. Whitley-Williams (NMA) observed that Dr. Lee’s slide on population-specific AESIs, the highrisk groups listed included children, pregnant women, the elderly, and those with co-morbidities. 

Although not applicable for all vaccine-preventable diseases, but certainly with COVID-19, 

certain under-represented populations have been disproportionately affected. Therefore, she 

wondered why under-represented minorities were not included in the population-specific list of 

AESIs.

Dr. Lee indicated that at this time, VaST is focused more on the general and platform-specific 

AESIs primarily because until they have the Phase III clinical trial data for all sub-populations, it 

will not be possible to assess which sub-populations of specific interest there will be. She 

expressed appreciation for Dr. Whitley-Williams raising the issue and emphasized that this was 

not a final list per se. Under-represented populations and those disproportionately affected by 
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COVID-19 disease are certainly a population under consideration. They will look at the clinical 

trials as they enroll diverse populations to determine whether there might be any differences 

between under-represented minorities versus others.

Enhanced Safety Monitoring for COVID-19 Vaccines in Early Phase Vaccination

Tom Shimabukuro, MD, MPH, MBA

Immunization Safety Office

Vaccine Safety Team

CDC COVID-19 Vaccine Planning Unit (VPU)

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

Dr. Shimabukuro provided an overview of enhanced vaccine safety monitoring for COVID-19 

vaccines in early phase vaccination. The challenge identified for safety monitoring in early 

recipients is that during the early phase of a national COVID-19 vaccination program, the initial 

doses may be distributed to specific groups such as healthcare personnel (HCP) and other 

essential workers. In this scenario, activities to enhance traditional vaccine safety monitoring 

systems such as VAERS will be necessary. The response will include preparing traditional 

monitoring systems as best as possible, conducting active surveillance in early recipients 

through smartphone- and email-based web surveys, and obtaining vaccination and safety 

monitoring data from healthcare facility and long-term care facility (LTCF) surveillance.

As a reminder, VAERS is the U.S. national spontaneous reporting or passive surveillance 

system early warning safety monitoring system that is co-managed by the CDC and the FDA. 

Anyone can submit a report to VAERS. Manufacturers are required to submit reports to VAERS 

of AEs that come to their attention. Reporting is now 100% electronic either through the VAERS 

portal for public report or through the electronic submission gateway for manufacturers. VAERS 

essentially has the entire U.S. population of roughly 320 million US residents covered for safety 

monitoring for all ages, races, states, healthy people, those with co-morbidities, et cetera. In 

recent years, VAERS has received approximately 60,000 reports per year or just over 1000 

reports per week.

VAERS serves as the nation’s early warning system to detect possible safety issues with U.S. 

vaccines, and traditionally has provided initial data on the safety profile of new vaccines when 

they are introduced for use in the population. COVID-19 vaccine report processing times will be 

quick. Processing times will be 1 day for reports of death, 3 days for reports classified as 

serious, and 5 days for reports classified as non-serious. These timeframes are from the time 

the reports are received until the time they become available to the CDC and FDA for analysis.

CDC and FDA receive updated datasets daily. During routine times each morning, the CDC and 

FDA receive a “Data Extract,” which is basically a refresh of the entire VAERS database.

In terms of VAERS analysis for COVID-19 reports, FDA scientists will review all VAERS reports 

classified as “serious” per routine. Attempts are made to follow-up on all serious reports to get 

medical records and other medical documentation. Based on the Code of Federal Regulations 

(CFR), a “serious” report is defined as a report of “death, life-threatening illness, hospitalization 

or prolongation of hospitalization, permanent disability, congenital anomaly or birth defect.” CDC 

scientists will review VAERS reports for AESIs. The CDC and FDA coordinate on the analysis of 
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VAERS data and both agencies conduct data mining. The following is a preliminary list of 

VAERS AESIs, which is subject to change and could expand or contract depending upon the 

results of the Phase III clinical trials and surveillance data in the post-authorization period as it 

begins to accumulate:

To demonstrate how quickly VAERS can accumulate data and characterize the safety profile of 

a new vaccine when it is authorized or approved and begins to be used in the population, 

Influenza A (H1N1) 2009 vaccines were licensed in mid-September 2009. They did not become 

available until well into October 2009. The analytic period for an analysis published in the 

MMWR on December 4, 2009 was through November 24, 2009. This is a matter of weeks from 

when CDC and FDA began conducting enhanced surveillance for H1N1 vaccines to the time 

this was published. The take-home message for this initial MMWR report was that the data were 

reassuring and that the safety profile for H1N1 vaccines was similar to that observed for season 

influenza vaccines.

Moving on to enhanced monitoring programs to meet the challenge of COVID-19, V-SAFE is a 

smartphone-based text, text-to-web survey, and email-to-web survey active surveillance 

program for early vaccine recipients. It uses contact information, including phone numbers from 

the registration process for COVID-19 vaccination of essential workers. This could be up to 20 

million people during the first few months of a vaccination program. Health checks of vaccine 

recipients will be conducted via text messages and email. These will be conducted daily during 

the first week post-vaccination and weekly thereafter for 6 weeks post-vaccination. Active 

telephone follow-up will be conducted with persons reporting a clinically important AE during 

any V-SAFE health check. These health checks are basically text messages that are sent out to 

the vaccinated individuals who can respond either by text, by clicking on a link to fill out a web 

survey, or by email in cases where there are no phone numbers. A VAERS report will be taken 

during telephone follow-up, if appropriate.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

16

CDC will have access to registered individuals. Upon notification that an individual has been 

vaccinated, CDC will begin the text messaging process. There is bidirectional communication of 

CDC reaching out to the vaccinated individual and them sending information back to CDC via 

the mechanisms described. Based on the responses received from vaccinated individuals, if any 

clinically important VE is reported by the vaccinated person, CDC will then transmit information 

to the existing VAERS call center to follow-up via phone with the individual and to complete a

VAERS report if appropriate. Per usual, those VAERS reports will go to the CDC and FDA. Here 

is a sample of a text that an individual would receive during the first week when receiving daily 

text messages:

The important component of this in terms of active follow-up for clinically important AEs occurs 

on the righthand side in that if an individual checks any one of the 3 boxes defined as clinically 

important, it would constitute a clinically important AE and would trigger the cascade of action 

where CDC sends the contact information to the call center for follow-up to take a VAERS 

report. While the clinically important AE in the text is fairly general, the VAERS report will be 

specific and will go through the normal VAERS process in which detailed information is 

collected on the signs and symptoms and goes through a Medical Dictionary for the Regulatory 

Activities (MedDRA) coding process.

CDC has validated the basic text messaging collection methods for vaccine safety monitoring. 

Smartphone-based safety monitoring of early COVID-19 vaccine recipients will allow for the 

estimation of rates of local and systemic reactogenicity and rates of clinically important AEs 

following immunization. Smartphone-based safety monitoring of early COVID-19 vaccine 

recipients will allow for the comparison of observed rates of AEs with background rates in the 

population and with known rates following other types of vaccinations such as influenza.

To describe enhanced VAERS reporting using the National Healthcare Safety Network (NHSN) 

sites, COVID-19 vaccine safety surveillance and facilitated VAERS reporting for healthcare 

workers and long-term care facility (LTCF) residents will occur through NHSN. NHSN is a CDC 

surveillance system with the principle purpose of monitoring healthcare-acquired infections 

(HAIs). The NHSN sites will track weekly vaccine doses administered by dose number in 

healthcare workers and LTCF residents, which is denominator data. The NHSN sites are well-
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

17

positioned to identify AEs among COVID-19 vaccine recipients at their sites, which is the 

numerator data. VAERS staff will match reports in VAERS to NHSN sites using facility address 

information, which means that the CDC can identify reports originating from NHSN facilities. 

This allows for calculation of crude overall reporting rates and AE-specific reporting rates.

To describe some of the established monitoring systems for a general vaccination program, 

national monitoring systems are robust and timely. VAERS reports are received and processed 

within days of program implementation. The CISA Project conducts case reviews upon request 

from U.S .healthcare providers. For the VSD and VA EHR monitoring systems, data are 

available on patients within a couple weeks of their encounter with the medical system. For FDA 

CMS data monitoring, which includes 650,000 nursing home residents, data may be available 

within several weeks of an encounter with a medical system. For FDA’s Biologics Effectiveness 

and Safety (BEST) and Sentinel and other large insurer/payer databases, data availability is 

variable depending upon the source, but can be available within a couple of weeks to several 

months of encounter with a medical system.

In summary, VAERS will play an important role in characterizing the safety profile of COVID-19 

vaccines in the early stages of a vaccination program. Signal detection is of paramount 

importance, but VAERS data can also provide reassurance if no concerning safety signals are 

detected, as in the case of H1N1 for which CDC was able to characterize the basic safety profile 

of the H1N1 vaccines relatively quickly. Additional systems such as V-SAFE and NHSN will 

enhance traditional vaccine safety monitoring systems, such as VAERS. Traditional large-linked 

database systems such as VSD, CMS, and VA EHR will quickly accumulate safety data when 

vaccines become widely available.

Discussion Points

In terms of V-SAFE, Dr. Szilagyi emphasized that the effectiveness of such a monitoring 

program depends upon adherence to the daily texts and responses and requested information 

about the experience that people have had with responding to those daily texts.

Dr. Shimabukuro indicated that much of the work with text monitoring at CDC has been done in 

the CISA Project. The response rates have been relatively high. In fact, rates have been 

surprisingly high in pregnancy studies. While he could not say that this would be generalizable 

to V-SAFE, generally speaking, the response rates for text monitoring and vaccine safety 

programs have been fairly good. This is a different situation, given that it is a much bigger 

program. Specifically, for the follow-up of clinically important AEs, multiple attempts will be

made to engage the person to obtain information on those. For V-SAFE, not following up might 

be an indication of the absence of AEs. While they need to be careful about how they interpret 

these, based on previous experience with text monitoring, CDC is hopeful that response rates 

will be decent.

Dr. Szilagyi said it was reassuring to him that many HCP, including himself, already are 

participating in daily symptom monitoring systems within their own healthcare systems as are 

teachers and many other essential workers. People seem to be getting used to quick daily 

monitoring.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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Dr. Atmar asked whether V-SAFE is opt-in or opt-out, exactly how participants would be 

recruited to do this, and whether this is envisioned as a condition for receipt through an EUA. 

He emphasized that with all of the discussion going on around the country and some people 

expressing concerns about the process of assessing the effectiveness and safety of these 

vaccines, continued monitoring of safety after the vaccine has been rolled out could be viewed 

by some with concern. They want the public to be reassured that any vaccine that is rolled out 

has gone through the appropriate review process and that this collection of additional safety 

information is what is done with all vaccine products, but is voluntary for those who will be the 

initial recipients of the vaccine.

Dr. Shimabukuro explained that for V-SAFE, they are essentially borrowing or leveraging 

information that is being collected as part of the registration process to identify essential workers 

for scheduling and for reminder recall. Part of the registration process is going to be to inform 

individuals that there is going to be outreach from CDC doing these health checks as part of the 

V-SAFE process. There will be an opt-out for these text messages. For example, when people 

are contacted initially after the vaccination, they will have the opportunity to opt-out. Being 

engaged in the program in general will be part of the registration process, which is broader than 

just vaccine safety. There are plans to develop some physical or electronic educational 

materials to be distributed at the point of service about what is being done, why it is important, 

and why participation would be appreciated.

Dr. Poehling expressed appreciation for the thoughtful approach to making sure everybody is 

included, including under-represented minorities. She asked whether there are plans to assess 

enrollment rates based on race and ethnicity and how the NSHN reflects the broader community 

and particularly under-represented minorities.

Dr. Shimabukuro indicated that he would have to get back to the group on the capture of racial 

data because they are essentially piggybacking onto the initial registration process and he did 

not know if these variables are being collected. There are tens of thousands of sites involved in 

NHSN across the country, including acute care facilities and LTCF. While he was not aware 

specifically if NHSN is representative of the population as far as race and ethnicity, there are 

many facilities, a large population, and a wide reach across the US.

Dr. Goldman asked Dr. Shimabukuro to comment on how he sees the role of community 

physicians in the reporting process or the enhanced reporting process.

Dr. Shimabukuro stressed that public reporting for VAERS is largely voluntary. It depends on 

members of the public submitting reports. Anyone can send a VAERS report, including patients, 

parents, caregivers, and HCP. It is very important that reports are submitted from HCP. 

Reporting of AEs is encouraged following immunization for any clinically important or clinically 

serious AE, or any AE regardless of whether the person is sure that the vaccine caused the AE. 

There will be education and outreach to HCP. They are a very important partner in vaccine 

safety monitoring and the information they provide in VAERS reports tends to be of high quality. 

CDC wants to make HCP and facilities aware of the importance of VAERS and receiving quick 

data in order to characterize the safety profile early. 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

19

Dr. Drees asked whether facilities would be asked to report raw numbers for both the numerator 

and denominator, or if they plan to ask for healthcare worker-level or recipient-level information 

for the numerator. NHSN facilities are very familiar with reporting raw numbers, which they do 

for influenza each year. Asking for patient-level or healthcare worker level data would be a 

significantly bigger ask, particularly for those that do not have an electronic capture system.

Dr. Shimabukuro indicated that NHSN reporting will be aggregate numerator and aggregate 

denominator with instructions and guidance of how to report the numerator into VAERS. This is 

traditional NHSN style reporting and will not be individual line list type data. At this point, the 

frequency of data reporting will be weekly. However, those discussions are still occurring.

Dr. Finley requested clarification regarding whether a condition for receipt of COVID-19 vaccine 

will be that the patient consents to allow their personal health information to be shared with 

CDC.

Dr. Cohn indicated that this would not be required.

Dr. Coyle (AIRA) asked whether it would be fair to assume that the information regarding the 

text message is going to come from the data clearinghouse that states will be leveraging for 

this.

Dr. Shimabukuro indicated that the actual sending of the text messaging would be from CDC or 

its information technology (IT) contractors and partners who are helping, not from the individual 

states.

Dr. Cohn added that the phone numbers for the text messaging will come from the registration 

process through multiple IT systems connecting state registration processes. However, no 

additional private information will be shared.

Ms. McNally asked whether CDC anticipates any feasibility challenges to the launch of V-SAFE 

in terms of timing or technical development, given the scale of this. She also wondered whether 

the programs referenced on Slide 14 were on the same scale as this.

Dr. Messonnier noted that those questions could be better answered during the next session, 

which would be more specifically about implementation.

COVID-19 Vaccine Implementation Planning Update

Janell Routh, MD, MPH

CAPT, USPHS 

Deputy, Implementation Planning Unit

Vaccine Task Force

Centers for Disease Control and Prevention

Dr. Routh explained that the Implementation Planning Unit consists of 3 teams, one that works 

specifically with jurisdictions on their planning process, one that is focused on planning for 

critical populations, and one that is working with CDC’s federal partners to help them administer 

vaccines to their respective populations. There is likely to be a relatively short period of time 

when vaccine doses will be limited, so CDC is directing its state, jurisdictional, and Tribal 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

20

partners to think about vaccine planning in 3 phases: 1) the first 3 to 6 weeks during which 

limited dosing will be available for prioritized populations; 2) a time during which there begins to 

be an increase in a large number of doses that will help to vaccinate other critical populations; 

and 3) a time during which there are sufficient doses for the population, when the emphasis 

switches to distributing vaccine to a broader population with a specific emphasis on populations 

that may require special consideration around distribution and equitable access.

To assist states, jurisdictional partners, and Tribal nations in this phased rollout of vaccine, CDC 

released the COVID-19 Vaccination Program Interim Playbook for Jurisdictional Operations (the 

“Playbook”) on September 16, 2020 with guidance for states to begin this planning process. In 

terms of some of the work that greatly informed the Playbook content, it builds on experiences 

from longstanding relationships that CDC staff in NCIRD have had with Immunization Managers 

across the US. It also leverages lessons learned from seasonal influenza campaigns, routine 

vaccination, campaigns, and prior outbreak-associated vaccination programs such as H1N1. 

That said, CDC recognizes that the COVID-19 response will be much more complex. 

This longstanding expertise helped to design a piloting effort that CDC put forth during the 

summer to help inform the Playbook content. In August 2020, CDC and Operation Warp Speed 

(OWS) staff met with 5 jurisdictions to assess their COVID-19 vaccine-specific plans. They 

selected North Dakota, Florida, California, Minnesota, and Philadelphia because of their 

diversity, size, and geography of their populations. In-person and virtual sessions were 

conducted with these jurisdictions, which allowed them to talk through the challenges in 

distributing COVID-19 vaccine. The feedback from these meetings helped to inform this interim 

Playbook. Other federal participants included the Indian Health Service (IHS) and the Assistant 

Secretary for Preparedness and Response (ASPR).

To highlight a few common themes that arose among all pilot sites, COVID-19 vaccination is 

going to be a resource-intensive endeavor, likely beyond what most jurisdictions currently have 

available. Jurisdictions are balancing significant COVID-related responsibilities with other 

routine immunization programs. Social distancing adds significant logistical complexity into 

COVID-19 vaccination event planning, so it is important to make sure that social distancing and 

infection control practices are implemented as part of vaccine rollout. Clear and transparent 

communication from CDC to jurisdictions is critical. Information gaps can challenge planning; 

therefore, it is important to quickly identify those gaps in order to solve problems before vaccine 

is rolled out. CDC began rolling out enhanced technical assistance (TA) to jurisdictions a couple 

of weeks prior to this meeting, which should help to mitigate some of the communication 

challenges. Technology concerns are persistent and significant. It is necessary to provide 

specific technical expertise in that area to make sure that jurisdictions are connected across the 

four avenues of vaccine release (i.e., allocation, distribution, administration, and tracking).

Public confidence in the vaccine process rates among the highest concerns for jurisdictions. 

The Implementation Planning Unit is doing some work to overcome vaccine hesitancy. Border 

communities (along city/state borders) highlight the need for clear guidance from CDC so that 

neighboring jurisdictions do not differ in their approaches to vaccination. To address that, CDC 

is standing up regional calls so that all of the 10 HHS Regions have an opportunity to come 

together to talk through issues that might be specific to their regions. Specific and uniform 

federal guidance on those to vaccinate in the earliest days of vaccine availability will lead to less 

complexity and fewer questions at the state/city levels. The prioritization list is driving a lot of the 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

21

current conversations. Vaccine allocation should consider the critical populations jurisdictions 

expect to vaccinate and not simply be based on their populations.

The Playbook released on September 16, 2020 has 15 sections that walk through all aspects of 

distribution and administration. This includes sections on engaging partners and establishing a 

COVID-19 Vaccination Program Implementation Committee to enhance the development of 

plans, reach of activities, and the risk crisis response in communicating message and delivery. 

One thing they tried to emphasize in the planning committees is to make sure that there is 

representation at the jurisdiction, local, and Tribal levels. One important aspect of the Playbook 

is that it stresses collaboration in working not only across the jurisdiction, but also with the local 

level partners, public health emergency preparedness programs, emergency management 

agencies, healthcare coalitions, industry groups, policymakers, and community vaccine 

providers to ensure that there is a well-represented committee that can think through these 

plans carefully.

The Playbook has sections that address how vaccine will be allocated, ordered, and distributed 

and how vaccine inventory will be managed. Most jurisdictions are planning to enroll vaccine 

providers to place orders using systems and procedures routinely used for ordering publicly 

funded vaccines, though some jurisdictions may have augmented systems for that. It is 

important to understand that this interim Playbook is a living document. CDC plans to update 

the content regularly as more information is learned about what vaccines will be available and 

when they will be released. Some updates that will be coming shortly will be additional 

information on reaching out to critical populations like LTCF; those who need special 

consideration for distribution and access like communities of color, rural populations, and those 

at increased risk for severe outcomes from COVID-19, such as the elderly. 

As previously mentioned, the CDC is implementing a system of enhanced TA to support this 

planning. The idea is to have daily interaction with jurisdictional partners to understand their TA 

needs and where they are in the development and implementation of COVID-19 vaccination 

plans. The teams consist of CDC Immunization Program Officers with a lot of expertise working 

with jurisdictional partners. The teams are augmented by IT SMEs. CDC received 10 DoD OWS 

liaisons who have special expertise in logistics, supply, and IT support to help augment these 

teams and provide additional TA to the states. Teams are organized by HHS Region and are 

expanding to include support and coordination with regional federal staff as well. Some of the 

tasks for which the teams are responsible will be to: 

 Collect and analyze metrics on jurisdictional capacity

 Provide direct TA to individual jurisdictions

 Facilitate cross-jurisdictional regional communication and collaboration so regions can learn 

from each other and think of creative ways to solve problems

 Train jurisdictions on the use of OWS’ Tiberius application and CDC’s internal dashboard to 

improve their microplanning and allocation processes

 Review and approve jurisdictional COVID-19 vaccination response plans, which is expected 

to occur rapidly after the plans are submitted to CDC 

 Support phased implementation of jurisdictional vaccination response

Every jurisdiction is heavily involved in their plan development. Even though the Playbook only 

went out the week before, states and jurisdictions have been thinking about this for quite some 

time and many have nearly completed their plans. Even though the TA is ongoing, the amount 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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of time already put into the planning process is very impressive. As noted, weekly calls will be 

held with all 64 jurisdictions and regional calls will continue to cross-populate ideas across the 

different regions. CDC also is collecting a series of metrics to ensure that jurisdictions are on 

track with their vaccination planning and to help identify areas that may need additional support.

In terms of next steps, work will continue with commercial partners and federal entities who may 

receive direct allocations to expand access to all populations. It will be necessary to pull in all 

resources. This is not just a jurisdictional effort alone. Jurisdictions also are being asked to 

collect vaccine provider agreements and onboard providers to be able to receive and administer 

vaccine, with a particular emphasis on providers who serve critical populations. Certainly, with

the early effort in Phase 1 having limited vaccine doses, the emphasis is on jurisdictions 

focusing on enrolling providers who can rapidly vaccinate populations of focus as soon as 

vaccine is available. This would include providers at large hospitals and health systems, mobile 

vaccination providers, satellite or temporary clinics, occupational health clinics, and critical 

access hospitals to ensure that the HCP population is saturated. In the next phase, jurisdictions 

are being asked to think critically about increasing the provider pool to include providers who 

can help expand equitable access to other critical populations and the general public. They are 

being encouraged to seek providers with connections in Tribal communities, rural health, and 

community health centers. Next is to enumerate critical populations who may be prioritized for 

early vaccine allocation or require special consideration for distribution and access. Jurisdictions 

are being asked to help CDC rapidly understand the number of HCP in jurisdictions so that they 

can plan accordingly.

Next is to begin engaging with community stakeholders to address vaccine hesitancy. Even as 

CDC works to develop a national strategy to address hesitancy, they know that most of that 

work will take place at the state and local levels. In addition to the communications staff who are 

currently working in the Task Force on an overall national plan, the Implementation Planning 

Unit has a team working on developing in-depth concepts of operations for populations that they 

think may have increased vaccine hesitancy. They are working to engage stakeholders at a 

national level that can then be translated down to the state and local levels so that they can 

begin the necessary work to strengthen overall immunization programs and COVID vaccination 

programs. Certainly, they will draw on lessons learned from their influenza colleagues since 

these populations are most similar to those most likely to be first prioritized for COVID 

vaccination. Finally, CDC is working with state, jurisdictional, and Tribal partners to ensure that 

data systems have processes in place to monitor vaccine distribution, uptake, demand, and 

wastage. CDC has an end-to-end data initiative underway that will ensure jurisdictions will have 

the visibility of COVID vaccine supply, and the data needed to accurately administer doses of 

vaccine, including second doses. Several new data systems are being finalized to help with 

collection, monitoring, and visualization of data necessary to mount a successful campaign 

(e.g., the OWS Tiberius platform, CDC’s internal dashboard, and other systems that jurisdictions 

can use to better track vaccines).

Discussion Points

Dr. Talbot said she could not imagine that the final cold storage requirements would be known 

for this vaccine before the deadline for the jurisdictions to complete and submit their plans. Also 

unknown are the best populations for efficacy and safety. With that in mind, she asked why the 

deadline is October 16th and if it is a hard deadline. It seems like there should be time to build 

connection with local officials. To have a deadline with no data seems somewhat premature.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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Dr. Routh agreed that the planning process is iterative. CDC is working with a current set of 

assumptions that was released to states in August. They are constantly learning more about 

vaccine products, storage and handling, et cetera and are anticipating some information about 

prioritized groups to come later. They are asking states to plan based on these assumptions, 

but they know the plans will be constantly improving and changing as new information is 

learned. The October 16th deadline was set based on the cooperative agreement regulations 

that states would return a plan to CDC 30 days after the Playbook was released. Given the fact 

that the Playbook was released on September 16th, they set October 16th as a deadline to be 

able to review the state plans. Again, states are being asked to think broadly. In their plans, they 

should have contingencies for whether there is an ultra-cold product only or more than one 

vaccine product becomes available. By thinking across that spectrum, when there is finally an 

answer, they can take a plan off of the shelf and run with it as soon as possible. Again, this is an 

iterative process and CDC is providing as much TA as possible to help states think through 

various scenarios. Although there is an October 16th deadline to return a plan, CDC will continue 

to work with its jurisdictional partners across the coming weeks and months to ensure that those 

plans are tailored as more information is available.

Dr. Messonnier added that it is important to understand that CDC has a lot of goals, one of 

which is to be ready on the first day that it is possible to actually distribute vaccines. Their 

colleagues in OWS say they expect there to be vaccine as early as November. Therefore, 

everyone needs to be ready so that there is no delay in distributing that vaccine. That early 

phase is close upon them. She asked everyone to think about planning in terms of phases. 

Based on data provided by their colleagues in OWS, CDC developed some scenarios they think 

are most likely. Moving out into 2021, more vaccines will be available and certainly more doses 

will be available. When CDC thinks about planning, they are thinking about not only the phase 

that is rapidly upon them, but also the second phase moving into 2021. They must be ready for 

the first phase imminently, but also recognize that in a lot of ways logistically, the movement of 

so much vaccine so quickly for the entire population is much more logistically challenging. 

Therefore, they must get started on that now. 

Dr. Hunter found the Playbook to be very helpful to those involved in implementation because it 

gives local and state health departments some guidelines to allocate vaccines on a micro level 

to venues being stood up by local health departments, healthcare organizations, community 

organizations, and pharmacies that will serve and vaccinate the kinds of groups the ACIP will be 

prioritizing. This helps connect the dots between what ACIP will eventually vote on, who the 

high-risk groups are, and the venues where many of those people will present. He commended 

CDC in being practical about that in the Playbook. The one thing he did not see is security at the 

sites. He is concerned about the threats of violence that have been perpetrated against leaders 

of public health that have led in part to the resignation of Commissioners of Health and the 

potential for disruption at vaccination events. He wondered if those issues will be addressed in 

future iterations of the Playbook.

Dr. Routh reported that CDC conducted a tabletop exercise with OWS in which they went 

through vaccine administration at a clinic site and thought through the security concerns. She 

agreed that the Playbook needs an update to address this, which CDC will be working to 

provide.

Dr. Bell requested further information about the tracking systems in terms of the kind of 

information that will be collected, the timing, who will assess the data, and other considerations. 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

24

Part of inspiring public confidence is having a mechanism for accountability, being able to report 

the status of vaccination and who is getting vaccinated and highlighting the issues that are 

developing early. She was happy to hear that CDC and OWS are working on various tracking 

methods. 

Dr. Routh said that they are in the process of finalizing a lot of these data systems to be able to 

roll them out through jurisdictions to help with their planning and tracking. It will be possible to 

give an update during a future ACIP meeting. Many of the jurisdictions will be using their 

Immunization Information Systems (IIS) either as they currently exist or in an augmented form to 

help with tracking. For jurisdictions that may choose not to use this or for clinics that may not 

have access to an IIS, CDC is in the final stages of developing a vaccine administration 

management system for use at standalone clinics that will provide similar features to an IIS and 

will allow providers to schedule appointments, register patients, and provide second dose 

reminders. This system is anticipated to be rolled out around the end of October. With regional 

teams, CDC will be able to provide some enhanced TA to support jurisdictions in getting up to 

speed with those systems. The OWS Tiberius platform will be rolled out to help states and 

jurisdictions do their microplanning. There is a microplanning tool and a dosing allocation tool 

that should be very useful. That system will also provide some additional visualization and 

tracking moving forward into the implementation process.

Ms. McNally asked whether there is a firm date for the launch of the V-SAFE program.

Dr. Messonnier indicated that the plan is to launch the V-SAFE program that Dr. Shimabukuro 

described with the first distribution of vaccines. Trial runs and backstopping will be done to 

ensure that there are no flaws in the system. CDC partly developed that system with an 

expectation, based on ACIP deliberations, of the first groups who would be prioritized for 

vaccination, which is HCP. A follow-up presentation can be provided during another ACIP 

meeting about the end-to-end data systems. It all comes together where there is a tool that 

people can use to register the vaccination sites to help with clinic management. There is the VSAFE tool for people to enroll in sites. The data are then rolled over so that they populate the 

registry system and then finally dump back in so that state and local health departments can 

use it and CDC gets an extract of it so that they can keep track of uptake and ensure that 

vaccine is being allocated appropriately. Explaining how all of these systems work together can 

be added to the agenda for the next meeting.

Disparities in COVID-19 Incidence, Severity, and Outcomes

Megan Wallace, DrPH, MPH 

Epidemic Intelligence Service Officer 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Wallace presented a brief update on U.S. COVID-19 epidemiology and data on disparities in 

COVID-19 incidence, severity, and outcomes, including disparities among racial and ethnic 

minority groups, that are driven by social determinants of health (SDOH).

As of September 20, 2020, a total of 6.7 million US COVID-19 cases have been reported to 

CDC. This map shows the cumulative case count by county, with the darker red representing 

larger numbers of cases: 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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In terms of the trends in the number of COVID-19 cases reported per day in the US, nationally 

cases peaked in mid-July and have been decreasing over the past 2 months. Based on the 

number of specimens tested for SARS-CoV-2 using a molecular assay and reported to CDC by 

public health laboratories, nationally, the percentage of specimens testing positive for SARSCoV-2 has continued to decrease since mid-July. During Week 37, the overall percent positive 

at public health laboratories was 4.5%. Among commercial laboratories reporting to CDC, the 

percentage of specimens testing positive also has been decreasing since mid-July. During 

Week 37, the percent positive was 4.8%.

As of September 20, 2020, a total of 198,754 deaths due to COVID-19 have been reported to 

CDC. This map shows the cumulative number of deaths by county, with the darker purple 

representing large numbers of deaths:
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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In terms of trends in the number of COVID-19 deaths reported per day in the US, nationally, 

deaths peaked first in mid-April and again in early August and have been decreasing over the 

past month. Regarding trends in pneumonia, influenza, and COVID-19 mortality, the National 

Center for Health Statistics (NCHS) collects death certificate data from Vital Statistics offices for 

all deaths occurring in the US. Based on death certificate data available as of September 17, 

2020, the percentage of deaths attributed to pneumonia, influenza, or COVID-19 for the week 

ending September 12th is 6.2%. While lower than the percentage for the previous week, it 

remained above the epidemic threshold and likely will increase as more death certificates are 

processed.

As shared in previous ACIP meetings, certain factors such as older age and having certain 

underlying medical conditions increases a person’s risk of severe COVID-19 disease. There is 

also increasing evidence that disparities in COVID-19 incidence, severity, and outcomes are 

occurring among people facing inequities in SDOH. SDOH are conditions in the places where 

people live, learn, work, and play that affect a wide range of health risks and outcomes. These 

broadly include economic stability; education; social and community context; health and 

healthcare; and housing, neighborhood, and built environment.

The Social Vulnerability Index (SVI) was developed by the CDC to identify communities that are 

at highest risk and may need the most support before, during, and after a public health 

emergency such as a pandemic. It is a measure of SDOH using U.S .Census Data and ranks 

each county and census tract on 15 social vulnerability factors and groups them into four related 

themes: Socioeconomics, Housing Composition and Disability, Representation of Racial and 

Ethnic Minority Groups, and Housing and Transportation.

The map on the left displays the SVI with those counties displayed in dark blue having the 

highest vulnerability. The map on the right displays COVID-19 cases per 100,000 residents with 

darker red representing counties with the highest COVID-19 incidence. These maps follow 

similar geographic patterns, indicating that many communities with high social vulnerability 

experience a high incidence of COVID-19:
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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Here, the map on the left remains the same and the map on the right now displays COVID-19 

deaths per 100,000 residents, with darker red representing counties with the highest incidence 

of death. Again, COVID-19 death rates also follow similar geographic patterns to high social 

vulnerability:

Using data from the SVI and U.S. county-level COVID-19 cases from June 1-June 25, 2020, a 

recent analysis examined associations between social vulnerability and the risk of becoming a 

COVID-19 hotspot, and among hotspot counties, described COVID-19 incidence after hotspot 

detection by level of social vulnerability. COVID-19 hotspots are counties with rapidly increasing 

COVID-19 incidence, identified using standard criteria developed by CDC. SVI scores were 

categorized as quartiles (Q) based on their distribution among all U.S. counties, overall and by 

urbanicity. Counties in Q1 had the lowest social vulnerability and counties in Q4 had the highest 

vulnerability. This study showed that the probability of becoming a COVID-19 hotspot was 2.4 

times higher for counties with the highest social vulnerability compared to counties with the 

lowest social vulnerability. This effect became even more pronounced in less urban areas. For 

example, in non-metropolitan areas, the probability of becoming a COVID-19 hotspot was more 

than 15 times higher for areas with the highest social vulnerability. This was particularly true for 

sub-scores related to racial and ethnic minority residents and housing composition, which led 

them to analyze these factors further. Comparing the relative risk of becoming a COVID-19 

hotspot by components related to racial and ethnic minorities and housing composition, counties 

at or above the national median percentage of racial and ethnic minority groups had an 

increased risk of becoming a COVID-19 hotspot compared to counties below the national 

median percentage. The association was particularly pronounced in non-metropolitan areas 

where the risk of becoming a hotspot was more than 8 times higher among counties with a 

higher percentage of racial and ethnic minority groups. The percentage of housing structures 

with ≥10 units or crowded structures increased the risk of becoming a hotspot only in 

metropolitan counties. The percentage of households with more people than rooms or crowded 

households increased risk more in non-metro counties. In terms of the incidence of COVID-19 

among hotspot counties by SVI quartile for the 14 days after detection as a hotspot, compared 

with less socially vulnerable counties (Q1-Q3), areas with the highest social vulnerabilities (Q4) 

continued to have markedly higher COVID-19 incidence [Dasgupta et al, CDC COVID-19 

Response Team: Manuscript in MMWR clearance].
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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There is increasing evidence that some racial and ethnic minority groups are being 

disproportionately affected by COVID-19. These disparities are seen in the disproportionate 

number of cases, hospitalizations, and deaths among these groups. Racial and ethnic minority 

groups represent 40% of the total U.S. population, but nearly 60% of COVID-19 cases. Based 

on case level data reported by health departments to CDC for approximately 5 million cases, 

among Hispanic or Latino, Black, and multiple or other race groups, the percentage of cases 

was higher than the percentage of the total population. This indicates a disparity in COVID-19 

cases among some racial and ethnic minority groups.

In another analysis among 79 U.S. counties identified as a hotspot between June 5-18, 2020, 

76 counties had a disproportionately high number of cases among racial and ethnic minority 

groups. In terms of the differences between the proportion of cases and proportion of the 

population and hotspot counties with disparities among racial and ethnic minority groups, if a 

group makes up 20% of the population of a county on average but 40% of COVID-19 cases, the 

difference would be 20%. The difference ranged from 4.5% for Native American Hawaiian and 

other Pacific Islanders to almost 40% in American Indians/Alaska Natives (AI/AN) [Moore et al, 

COVID-19 State, Tribal, Local, and Territorial Response Team, August 2020

https://www.cdc.gov/mmwr/volumes/69/wr/mm6933e1.htm].

Disparities in severe COVID-19 disease are observed by the differences in COVID-19 

associated hospitalizations among racial and ethnic minority groups. COVID-NET is a 

population-based surveillance system collecting laboratory-confirmed COVID-19 associated 

hospitalizations in 14 states. In terms of the age-adjusted cumulative rate of hospitalizations by 

week reported to COVID-NET, as of MMWR Week 35 or August 29th, hospitalization rates 

among AI/AN, Black, and Hispanic persons were more than 3 times the rate among White and 

Asian persons. Racial and ethnic disparities in COVID-19 hospitalization rates among racial and 

ethnic minority groups occur in both young and older age groups. In younger adults 18-49 years 

of age, hospitalization rates among AI/AN and Hispanic persons were higher. In older age 

groups ≥65 years of age, hospitalizations were higher among Black persons. Racial and ethnic 

minority groups represent 40% of the U.S. population, but nearly 50% of COVID-19 deaths. 

Among Black and multiple/other racial groups, the percentages of deaths were higher than the 

percentage of the total population indicating a disparity in COVID-19 deaths among these 

groups. In terms of the differences between the percent of COVID-19 deaths and the weighted 

population distribution by race and ethnicity and age group from death certificate data, persons 

reported as Hispanic, Black, and AI/AN all experienced disparities in COVID-19 deaths in the 

age groups less than 65 years, with the greatest disparities observed in the youngest age 

groups.

Regarding data on race and ethnicity by age group among a convenience sample of 10,000 

COVID-19 deaths that occurred during February 12-April 24, 2020 in 16 health jurisdictions, the 

median age was 71 years among Hispanic decedents, 72 years among all other race 

decedents, and 81 years among White decedents. The percentages of COVID-19 decedents 

who were less than 65 years in Hispanic or other race groups were more than twice those that 

were White [Modified from: Wortham et al, 2020, https://www.cdc.gov/mmwr/volumes/69/wr/ 

mm6928e1.htm].
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

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Some of the many inequities and SDOH that put racial and ethnic minority groups at increased 

risk of getting sick and dying from COVID-19 include discrimination; healthcare access and 

utilization gaps; occupation in higher risk settings; education, income, and wealth gaps; and 

housing that is crowded or lacks basic services. For example, in New York City (NYC), the 

percentage of COVID-19 tests increased significantly with the increasing percentage of White

residents [Lieberman-Cribbin et al, September 2020, https://doi.org/10.1016/j.amepre. 

2020.06.005].

Some racial and ethnic minority groups are more likely to be employed in essential industries or 

in occupations with frequent exposure to infections and in close proximity to others. For 

example, a study by Hawkins and colleagues showed that 38% of Black persons are likely 

employed in an essential industry compared to 27% of White persons [Hawkins, May 2020: 

https://doi.org/10.1002/ajim.23145].

In terms of the association between poverty, representation of racial and ethnic minority groups, 

and COVID-19 rates using data from 10 U.S. urban centers, counties with more poverty 

(defined as those counties with a poverty rate above the median of the dataset) had higher 

COVID-19 rates. These rates increased with increasing percentage of racial and ethnic minority 

groups. In counties with more poverty and a population that was more than 44.5% racial and 

ethnic minority groups, the COVID-19 rate was nearly 8 times that of counties with substantially 

White populations [Adhikari et al, July 2020, doi:10.1001/jamanetworkopen.2020.16938].

In a large health system in Louisiana, SDOH such as residence in a low-income area and 

insurance type were independently associated with increased odds of COVID-19 hospitalization. 

Black race also was independently associated with an increased odds of COVID-19 

hospitalization [Price-Haywood EG et al. N Engl J Med 2020;382:2534-2543].

Racial and ethnic minorities are disproportionately impacted by the COVID-19 pandemic. Black, 

Native American, and Hispanic persons reported elevated levels of suicidality, depressive 

symptoms, and fear of COVID-19. Non-Hispanic Black persons are more likely to experience 

loss of a close relative due to COVID-19 than non-Hispanic White persons. Non-Hispanic Black 

and Hispanic persons are more likely to report food insecurity during the COVID-19 pandemic 

[Source: Fitzpatrick et al, June 2020, https://doi.org/10.1111/sltb.12655; Verdery et al, July 

2020, https://doi.org/10.1073/pnas.2007476117; Wolfson and Leung, June 2020, doi: 

10.3390/nu12061648].

In summary, as of September 20th, over 6.7 million cases of COVID-19 have been diagnosed 

and over 198,000 COVID-19 associated deaths have been reported in the US. Racial and 

ethnic minority groups are being disproportionately affected by COVID-19, including increased 

risk of infection, hospitalization, and deaths. Inequities in SDOH put racial and ethnic minority 

groups at increased risk of getting sick and dying from COVID-19.

Discussion Points

Dr. Szilagyi observed that the depiction of racial and ethnic disparities was very sobering. He 

wondered whether social vulnerability could be overlayed with the proportion of all COVID-19 

cases that are in large metropolitan areas, medium metropolitan areas, and non-metropolitan 

areas—thinking about non-metropolitan areas being at higher risk of social vulnerability.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

30

Dr. Dasgupta indicated that they looked at incidence in metropolitan versus non-metropolitan 

areas. Interestingly, there was a shift in higher incidence in less urban areas during the summer 

months. Incidence was higher in non-metropolitan areas as well as small and medium 

metropolitan areas compared with large metropolitan areas. Strikingly, SVI scores were higher 

among those areas as well. There was a shift in the proportion of counties with high social 

vulnerability that were identified as hotspots in the summer months as well. These particular 

hotspot areas continue to have high incidence, especially among socially vulnerable areas.

Dr. Whitley-Williams (AMA) suggested working to understand whether bias is playing a role in 

this. For instance, assessing ethnicity in terms of how many of the patients who died never 

made it to the hospital or how many of these patients were seen at a healthcare facility or by a 

HCP and sent home.

Dr. Wallace indicated that they would determine whether they have any data to address the 

potential for bias playing a role and will get back to the group. Many of the studies have found 

that among a population already hospitalized, many of the disparities are not seen in deaths. 

Disparities in deaths are driven a lot by disparities in incidence. However, there is probably 

more they could look into regarding this.

Dr. Oliver added that from a surveillance standpoint, COVID-NET is limited to patients who 

are hospitalized. Dr. Wortham’s MMWR included any type of COVID-related death that had 

been reported from any site. Looking at the difference between those two would be assessing 

the difference in the people hospitalized, while acknowledging the larger question that there are 

likely additional disparities that could come with lack of healthcare access as well.

Dr. Lee wondered how SVI information could inform implementation efforts and asked whether 

vaccine distribution would be tracked to these communities.

Dr. Cohn said that CDC has been thinking about ways to use this type of data to help 

jurisdictions and commercial and private partners to ensure access and availability of vaccine in 

these targeted areas when vaccine is widely available. Ensuring access and demand and 

working with community and local stakeholders in these vulnerable communities will be very 

important.

Dr. Poehling asked whether there has been a sub-analysis of hotspots with incarcerated 

populations and in meat packing plants.

Dr. Oliver indicated that there are specific groups within the response who are looking at these 

populations. Some of their data have been presented previously in terms of correctional facilities 

and cases associated with workplace outbreaks.

Dr. Gluckman noted that over time there have been some advances in therapy, which could 

result in a reduction in disparities.

Dr. Fryhofer (AMA) emphasized that these disparities are striking and disturbing. The FDA 

issued special guidance on June 30, 2020 for the vaccine makers to include diverse populations 

in all study phases. Of the two vaccines ACIP has reviewed, one has only 28% and the other 

only 26% diversity as they heard earlier in the day. Perhaps those percentages should be 

increased to 40% racial and ethnic minorities to better reflect the general population. Efforts 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

31

should be made now to instill confidence in these vaccines among racial and ethnic minority 

groups so that when there is a vaccine they will be willing to take it.

Dr. Oliver reported that in discussions with FDA and manufacturers, ACIP has continued to 

reiterate that the composition of these clinical trials should mirror the population of the US.

Dr. Cohn added that ensuring that all individuals, including racial and ethnic minorities, are 

confident in getting the vaccine will be crucial to the success of the vaccine program. CDC has 

implemented community-level engagement with regard to influenza vaccine and is hoping that a 

lot of the work done in that space will help with COVID-19 vaccine engagement. Based on 

everything they have learned over the last year, it is imperative to engage communities at a very 

local level in addition to ensuring that messages are culturally competent, targeted, empathetic, 

clear, and accurate in terms of the information provided. The efforts to increase vaccine 

confidence is likely to expand more rapidly when there are data about the vaccines to 

incorporate into the messaging. Right now, messaging is in the preparation phase and is very 

broad. When there are safety and efficacy data that they can message, there will be a big push 

to ensure that these communities understand the messages and are hearing them from people 

who they trust.

Dr. Romero added that the message must begin now. It cannot wait until the vaccine is on the 

precipice of being released. Speaking from his own experience, the advisory groups that advise 

the Arkansas Department of Health have reported that there is an extreme lack of confidence in 

this vaccine among under-represented minorities. He has been trying to reach out to the Latino 

population by providing specific targeted talks to leaders of that group.

Dr. Arthur (BIO) wondered whether it would be possible to have a breakdown of the racial and 

ethnic differences in the populations by metropolitan and non-metropolitan areas. She said her 

suggestion was intended to understand specifically which racial and ethnic groups comprise the 

populations under each geographic description. For example, are the populations in non-metro 

areas largely Native American or is the distribution between the communities largely the same 

across all races?

Dr. Dasgupta said that there is a larger proportion of racial and ethnic minorities in large 

metropolitan areas compared with smaller, less urban areas.

Dr. Frey agreed with Drs. Fryhofer and Romero that the country must be extremely proactive in 

educational pieces for racial and ethnic minority populations, essential workers, and people of 

low socioeconomic means so that individuals will be confident about taking vaccines. She would 

like to know who actually does this work, at what level it is done, the types of efforts being 

made, and when this will begin. Perhaps a presentation to ACIP on this would be beneficial.

Dr. Cohn indicated that multiple entities will contribute to activities to increase confidence at the 

state, local, Tribal, community, non-governmental, and governmental levels. CDC hears the 

message that this work needs to begin now, and it is beginning in many communities.

Dr. Eckert (AGOC) asked whether there are any data about the pregnancy status of the women 

presented in the disparities data and maps so that they could ascertain whether the same 

trends are following for pregnant women.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

32

Dr. Oliver indicated that this specific issue will be addressed during a future ACIP meeting once 

the information is assembled to present.

Dr. Lee took a moment to recognize their CDC colleagues who are working incredibly hard 

behind the scenes to stand up multiple systems and communication processes in this extremely 

challenging climate. While she agreed that it is challenging to communicate around vaccines 

and vaccine confidence without actually having the clinical trial data in hand, perhaps one thing 

they could do together would be to continue to emphasize the process for decision-making and 

how much emphasis they are all placing on transparency and the importance of that. Trusted 

voices will definitely be needed from providers, community leaders, and others to convey 

confidence in vaccines. She expressed her hope that working with liaison organizations going 

forward would continue to be a strength. She recognized that this goes well beyond CDC and 

emphasized the importance of working together to support what is needed.

Dr. Messonnier recognized that this is a challenging time for everyone, but that they all believe 

that COVID-19 vaccines could be a very important part of the solution. The groundwork will be 

very important to ensure that people are ready, willing, and confident when vaccines become 

available.

Dr. Bell said she liked the idea of the SVI because it integrates so many different factors and 

ties in closely with geography. She asked about the extent to which anyone at CDC thinks that it 

is feasible to use the SVI as a tool in implementation planning.

Dr. Cohn thinks it is quite feasible and these factors can all be incorporated into local planning 

to provide information to programs to help target their efforts. Local and state programs know 

their communities, frequently even more than the data show. Combining the expertise of local 

and state programs with the power of understanding some of the data based on SVI is very 

important and will be implemented.

Dr. Foster asked whether any analyses have been performed with regard to behavioral 

compliance, such as masking, to ascertain the degree of protection people who got sick were 

using or not using to protect themselves. He hears a lot of people say that they do not believe 

this, and they will not wear a mask.

Dr. Oliver indicated that aspects within the response have examined that broadly, but they have 

not presented that directly to ACIP at this point. There are communications and messaging on 

CDC’s Home Page that could help to address that.

Ms. Bahta said that being on the local side of planning, they know what venues and avenues 

can be used to provide messages. However, the many national messages right now make it 

very difficult to provide the context around what is really occurring. As mentioned before, the title 

“Operation Warp Speed” scares a lot of people. It would be helpful if national leaders from FDA 

and CDC could talk about what that means in plain language. Being able to visualize what this 

means might assuage people’s anxiety about COVID-19 vaccination.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

33

Overview of Vaccine Equity and Prioritization Frameworks 

Sara Oliver MD, MSPH 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Oliver reminded everyone that ACIP has discussed the inclusion of ethics and equity 

principles as a part of the process to identify proposed groups for early COVID-19 vaccination. 

As a first step, the WG reviewed frameworks and published literature related to COVID-19 

vaccine allocation. Several groups have published frameworks for early vaccine allocation, 

including the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE), 

the Johns Hopkins Bloomberg School of Public Health (JHSPH), and the National Academies of 

Science, Engineering and Medicine (NASEM).

The WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 

Vaccination includes both national and global considerations with the six core values principles 

of: human well-being, equal respect, global equity, reciprocity, legitimacy, and national equity. In 

this framework, the priority groups were not ranked and were relatively broad. They include 

populations with significantly elevated risk of being infected, such as healthcare workers, 

employment categories unable to physically distance, or persons living in crowded conditions. 

They also include populations with elevated risk of severe disease or death, including older 

adults, groups with comorbidities, and sociodemographic groups at disproportionately higher 

risk of severe disease and death.

The purpose of the JHSPH Interim framework for COVID-19 Vaccine Allocation and Distribution 

in the United States is to identify candidate groups for serious consideration as priority groups, 

and demonstrate how ethical principles and objectives can be integrated to produce an ethically 

defensible list of candidate groups. The authors note the importance of transparency and a fair 

process; equity, including access to healthcare; and community outreach and engagement. The 

structural organization of the JHSPH framework includes three ethical values linked to seven

ethical principles. Those are then linked to 11 policy goals, which are linked to 12 objectives, 

which ultimately lead to the priority groups. The ethical values include promoting the common 

good; treating people fairly and promoting equality; and promoting legitimacy, trust, and a sense 

of ownership in a pluralistic society. 

In terms of JHSPH’s priority groups for Tier 1, first are those most essential in sustaining the 

ongoing COVID-19 response, including frontline HCP caring for COVID-19 patients, frontline 

emergency services personnel, vaccine manufacturing, diagnostics, and public health workers. 

Next are those at greatest risk of severe illness and death and their caretakers, including adults 

65 years of age and older and those who care for them, others at increased risk of severe 

disease, frontline LTCF providers, and HCP caring for patients with high risk conditions. Third 

in Tier 1 are those essential to maintaining core societal functions, including public 

transportation, food supply workers, and teachers.

The groups included in Tier 2 of the JHSPH framework are those involved in broader health 

provision, including other HCP and pharmacy staff; those who face barriers to access to care, 

including those living in remote locations; those needed to maintain other essential services, 

including deployed military, police and fire, Transportation Security Administration (TSA) and 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

34

border security; and finally, those whose living or working conditions give them elevated risk of 

infection, including those living in congregate settings.

The NASEM Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID19 Vaccine defines their purpose as being to develop an overarching framework for vaccine 

allocation to assist policy makers in domestic and global health communities in planning for 

equitable allocation of vaccines. They note the expectation that the framework will inform 

decisions by health authorities, including ACIP. They were asked to consider criteria for setting 

priorities for equitable allocation, and how to apply the criteria to determine the 1st tier of 

recipients. The major elements of the NASEM framework structure are an overarching goal, 

allocation criteria, and allocation phases. NASEM identified six foundational principles:: 

maximize benefits, equal regard, mitigate health inequities, fairness, evidence-based, and 

transparency. They state that their overarching goal is to maximize societal benefit by reducing 

morbidity and mortality caused by transmission of COVID. Their allocation criteria are based on 

the risk of acquiring infection, risk of severe morbidity and mortality, risk of negative societal 

impact, and risk of transmitting disease.

Their vaccine allocation phases are: 1) Phase 1a, or a “jumpstart phase,” which includes high 

risk workers in healthcare facilities and first responders; 2) Phase 1b, which includes people of 

all ages with underlying conditions that put them at significantly higher risk, defined as two or 

more CDC designated medical conditions, and older adults living in congregate settings; 3) 

Phase 2, which includes critical workers at substantial risk of exposures, teachers and school 

staff, people with any underlying condition, all older adults, people in homeless shelters or group 

homes, and people in prisons/jails/detention centers; 4) Phase 3, which includes young adults, 

children, and the remainder of essential workers; and 5) Phase 4, which includes everyone not 

previously vaccinated.

Here are the three frameworks in one table and organized by the four groups ACIP has 

previously discussed: HCP, other essential workers, persons with underlying medical 

conditions, and adults ≥65 years of age:
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

35

The WHO priority groups included all four of these populations, but were unranked, so further 

details are not able to be provided. For HCP, both Hopkins and NASEM placed “frontline” HCP 

in Tier 1 or Phase 1, with other HCP included in the next Tier or Phase. Among other essential 

workers, teachers and school workers are in Tier 1 of the Hopkins framework, but in NASEM’s 

Phase 2. Hopkins included police and fire in Tier 2 while NASEM placed them in Phase 1a. For 

adults with underlying medical conditions, Hopkins includes all in Tier 1; NASEM includes those 

with two or more underlying conditions in Phase 1b, and adults with one underlying condition in 

Phase 2. For adults 65 years of age and older, Hopkins includes them in Tier 1 and NASEM 

includes those in congregate settings in Phase 1b and all others in Phase 2.

The ACIP COVID-19 Vaccines WG interpretation of the frameworks when they were presented 

and discussed was as follows: all published frameworks identify HCP as important for early 

phase vaccine allocation. However, after HCP, all frameworks have large population sizes for 

the next doses of vaccine. The populations in Tier 1 or Phase 1 likely have 50 million individuals 

or more, which may be more than initially available vaccine doses. The WG also felt that many 

of the identified populations contain operational or implementation difficulties. For both 

frameworks, essential workers are split across different Tiers and Phases, which could be 

difficult to implement. In addition, the identification and delivery of vaccine to only those with two

or more underlying medical conditions would be very difficult to operationalize. Finally, both 

frameworks separate out “frontline” HCP from other HCP. However, the epidemiology of 

COVID-19 disease among HCP demonstrates that that cases and risk of disease extend 

beyond only “frontline” HCP.

Equity was considered as a crosscutting consideration for all three of the frameworks. Hopkins 

discussed the importance of promoting equity and social justice; the NASEM discussed using 

CDC’s SVI; and WHO stated that these vaccines should contribute to equitable protection of 

people around the world. 

ACIP has proposed an ethics/equity framework for COVID-19 vaccine allocation. The purpose 

of the framework is to assist ACIP in the identification of early recipients for allocation of COVID19 vaccine in the setting of a constrained supply. The goals are to minimize death and serious 

disease, preserve the functioning of society, reduce disproportionate burden on those with 

existing disparities, and increase equity of opportunity to enjoy health and well-being. After 

discussions with SMEs and with the ACIP COVID-19 Vaccines WG, the five proposed ethical 

principles for the ACIP ethics/equity framework are: maximize benefits and minimize harms, 

equity, justice, fairness, and transparency.

First, the ethical principle to maximize benefits and minimize harms includes minimizing death 

and serious disease, addressing the obligation to promote public health and promote the 

common good, balanced with the obligation to respond and care for persons, and based on the 

best available science. The equity principle will help orient discussions to make sure that 

vaccine allocation reduces, rather than increases, health disparities and ensures that everyone 

has a fair and just opportunity to be as healthy as possible. The justice principle involves a 

commitment to remove unfair, unjust, and avoidable barriers to good health and well-being that 

disproportionately affect the most disadvantaged populations, as well as intentionally ensuring

that groups, populations, and communities affected by a policy are being treated fairly. The 

fairness principle includes a commitment to fair stewardship in the distribution of a scarce 

resource, with equitable distribution of benefits and burdens; not exacerbating existing 

disparities in health outcomes; providing equal opportunity to access vaccine; and consistency 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

36

in implementation. Finally, transparency is essential to building and maintaining public trust 

during vaccine program planning and implementation. Achieving transparency requires that the 

supporting principles and processes for allocation decisions are clear, understandable, and 

open for review. This involves to the degree possible, given the urgency of the response, that 

public participation in the creation and review of the process is recognized and honored and 

that all recommendations are evidence based, with information used to make recommendations 

publicly available.

All ACIP recommendations for COVID-19 vaccines must be ethically principled, evidencebased, and feasible for implementation. GRADE and the EtR framework will be used to ensure 

recommendations are evidence-based. Dr. Dooling’s upcoming presentation will have further 

discussions around whether the recommendations are feasible for implementation. The 

remainder of this talk will focus on the steps taken to make sure ACIP recommendations are 

ethically principled.

Dr. Oliver next walked through the four populations discussed previously, using the proposed 

framework. SMEs and the WG felt that the transparency principle was more about the process 

than each individual population, and as such would be more of a foundational principle across 

the entire framework. In addition, all ACIP recommendations are evidence-based and this 

serves as an overarching principle.

First, for HCP:

Under maximize benefits, HCP are essential for the response. Protecting HCP may decrease 

transmission to patients, coworkers, and the community and may decrease morbidity and 

mortality among this population. Nearly 40% of HCP have a high risk condition or are 65 years 

of age and older. HCP may serve in low redundancy jobs where absenteeism may compromise 

care. Under equity, there is an over-representation of some racial or ethnic minority groups and 

lower income earners. Seroprevalence of SARS-CoV-2 is higher among Hispanic and nonHispanic Black HCP, and a larger proportion of staff at LTCF are female, non-Hispanic Black 

persons and disproportionately lower-wage workers. Under justice, HCP recommended for early 

phase vaccination should have equal opportunity to access the vaccine. In addition, the 

definition of HCP is broad and includes paid and unpaid persons serving in healthcare settings. 

Under fairness, vaccination of HCP could help reduce disparities in health outcomes and it 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

37

acknowledges the increased risk of exposure due to the nature of work. Finally, transparency 

involves engagement with partners and key stakeholders, as well as discussion at public 

meetings.

Next moving to other essential workers:

Under maximize benefits, their work is essential for the response or functioning of society. 

Protection of other essential workers may decrease transmission to work and community 

contacts and could decrease outbreaks in some work settings or sectors such as food and 

agricultural plants and correctional facilities. Under equity, there is an overrepresentation of 

minority groups in some sectors of essential workers, with racial or ethnic minority populations 

representing nearly 90% of cases in meat or poultry processing plants, and 73% of cases in 

workplace outbreaks in Utah. Under justice, workers should have an equal opportunity to 

access vaccine. Under fairness, vaccination of essential workers could help reduce disparities in 

health outcomes and it also acknowledges the increased risk of exposure due to high density 

workplaces and the inability to work remotely. Transparency remains a foundational principle. 

Next are adults with high-risk medical conditions:
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

38

Under maximize benefits, protection among adults with high-risk conditions could reduce 

morbidity and mortality: 60% of hospitalized adults and 80% of adults who died had three or 

more underlying conditions. Under equity, racial and ethnic minority groups have increased 

prevalence of many high risk conditions, with data on obesity presented in the table. In addition, 

the prevalence of underlying medical conditions is higher in counties in the Southeastern US 

and rural communities, where the SVI is generally higher. Under justice, persons recommended 

for early phase vaccination should have an equal opportunity to access vaccine. Under fairness, 

providing vaccine to adults with high-risk medical conditions can help reduce disparities in 

health outcomes. Again, transparency is a foundational principle.

And finally, for adults 65 years of age and older: 

Under maximize benefits, providing vaccine to this population could reduce morbidity and 

mortality. Adults 65 and older represent 16% of cases, but nearly 80% of deaths. However, 

there are other things to consider in this population. Under equity, Hispanic and non-White 

decedents are under-represented among COVID-19 deaths in adults 65 years of age and older. 

Under justice, the HHS Office for Civil Rights (OCR) has stated that a strict age cut-off or agebased criterion alone is not recommended for use in ventilator or resource allocation. Under 

fairness, Persad and co-authors have stated that a “healthy older person who can shelter in 

place is at different risk from a medically vulnerable older person in a crowded housing

environment.” The American Geriatric Society (AGS) submitted a statement to NASEM after 

their draft framework was released stating that “age should never be used to exclude someone 

categorically from a standard of care, nor should age cutoffs be used in allocations.” This public 

comment shows the importance of transparency as a foundational principle as well.

The next steps are to continue to progress the development of an ACIP ethics/equity 

framework. The WG is happy to receive input from ACIP regarding the five proposed ethical 

principles and their application. The WG is also planning further discussions about application of 

the framework to “Phase 1” allocation discussions and future recommendations. In addition, 

there are discussions around how ethics and equity can formally be incorporated into the EtR 

framework for COVID-19 vaccines, and hopefully, more broadly to other vaccines as well.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

39

Discussion Points

Dr. Szilagyi expressed his support for the five proposed ethical principles for the ACIP 

ethics/equity framework of: maximize benefits and minimize harms, equity, justice, fairness, and 

transparency. He thinks these are the right principles and that they overlap very nicely with the 

best components of the SAGE, Hopkins, and NASEM models. One of the challenges is that 

they must remember that over months, the vaccine supply will increase. Therefore, these 

decisions would have to be made for a shorter time period. There is wide diversity of risk within 

each of these groups, but it is very difficult to figure out the actual risk for an individual person. 

Some sort of a principle is needed that follows the rules of simplicity and offers the ability to 

identify individuals.

As the WG Chair, Dr. Bell encouraged other ACIP members and liaisons to weigh in on their 

sense of whether this is heading down the right track and if they feel that a framework like this 

would help them. While she completely agreed with what Dr. Szilagyi said about not wanting to 

be so totally focused on something that hopefully will last a relatively short period time, showing 

that they have thought about all of these issues very carefully and are transparent about it will 

be helpful for inspiring public confidence.

Dr. Poehling agreed that this is exactly the type of information needed to think clearly about how 

to maximize the benefit and minimize the harm. This is a very transparent way to do this. She 

agreed with all of the principles and thought it was an excellent start.

Dr. Hunter also agreed with the principles. He pointed out the importance of understanding who 

would apply these principles early. Hopefully, it will not be the individual clinician or nurse at the 

point-of-care dealing with an individual patient or client. Instead, it should be used on a more 

programmatic level at the state and local health department and healthcare system levels with 

flexibility to decrease potential conflict at the point-of-care between the vaccinators themselves 

so there can be some flexibility at the site. In order to increase confidence in general and gain 

trust and cooperation, political leaders and scientific experts together need to come to 

consensus behind this. Unified delivery of messages that are evidence-based recommendations 

and these unified principles are the way to go and will make the jobs of ACIP and state health 

departments much easier.

Dr. Fryhofer (AMA) thanked ACIP for the thoughtful and methodical process they went through 

with respect to these principles. Weigh in from the WHO/SAGE, Hopkins, NASEM, and AGS 

added credibility to this process. She expressed great appreciation for the transparency

foundational principle mentioned. The AMA had an opportunity to weigh in on the NASEM 

recommendation. She clarified that under the four-phase approach, physicians, healthcare staff, 

and private practices involved in direct patient contact and who are, therefore, at increased risk 

of exposure, should be eligible for vaccine in Phase 1. These physicians and HCP may not have 

access to personal protective equipment (PPE) that physicians and others have in larger 

facilities.

Dr. Atmar found this to be an outstanding framework that set the groundwork for the difficult 

work ahead, which is further deciding how to roll out the vaccine to various groups. He echoed 

Dr. Szilagyi’s comment about trying to keep it simple to implement and Dr. Hunter’s comments 

about the importance of guidance. His own healthcare system has begun to struggle with how 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

40

vaccine that becomes available should be allocated within the healthcare system. They are 

racing against time to be prepared to do this, but there is still the very real challenge of trying to 

figure out within these groups how to further sub-divide.

Phase 1 Allocation COVID-19 Vaccine: Work Group Considerations

Kathleen Dooling, MD MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling presented WG considerations for Phase 1 allocation of COVID-19 vaccines. The 

WG envisions the overall goals of a COVID-19 vaccine program to be to: 1) ensure the safety 

and effectiveness of COVID-19 vaccines; 2) reduce the transmission, morbidity, and mortality of 

COVID-19 disease; 3) help minimize disruption to society and the economy, including 

maintaining healthcare capacity; and 4) ensure equity in vaccine allocation and distribution. 

From the beginning, the WG established guiding principles to help achieve these goals. The first 

guiding principle is that safety is paramount. Second, clinical trials should be inclusive. Third 

and fourth, and most pertinent to this presentation, are the desire for efficient distribution of 

vaccine and flexibility within national guidelines.

As mentioned a number of times throughout the day, administration of COVID-19 vaccines will 

require a phased approach. Once a vaccine is approved for use, there likely will be insufficient 

supply to meet demand. In August, ACIP heard about cold-chain storage and handling 

requirements of -700 and -200 Celsius, which may require specialized equipment and high 

throughput in clinics. In the second and third phases of this vaccine rollout, sufficient vaccine 

supply and a broadening of the implementation strategies to reach everybody who wants to be 

vaccinated are anticipated. This session focused on the first phase, that projected short period 

of time when vaccine doses may be limited and administration will need to be targeted, and how 

the objectives of the program can best be achieved during this period.

During the August emergency meeting, ACIP members voiced support for HCP to be offered 

vaccine during Phase 1a. Phase 1b groups included essential workers outside of healthcare, 

adults with high-risk medical conditions, and adults 65 years and older. The Phase 1b groups 

were further explored during the September meeting, with a review of their risk for COVID-19, 

the overlap between groups, their racial and ethnic composition, and a summary of the WG 

considerations for each group. These two questions were posed for ACIP to consider while 

hearing the presentation:

 If constrained vaccine supply necessitates sequencing of groups in Phase 1b, what are the 

most important information gaps we need to fill for ACIP to make sequencing 

recommendations?

 What is the correct balance of national guidance and local flexibility?

As mentioned, there was broad support from ACIP for inclusion of HCP in Phase 1a of a 

COVID-19 vaccine program. HCP are defined as “all paid and unpaid persons serving in 

healthcare settings who have the potential for direct or indirect exposure to patients or infectious 

materials.” The estimated population for this group is 17 to 20 million people in the US. Although 

not exhaustive, some examples include HCP who work in hospitals, LTCFs (including assisted 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

41

living and skilled nursing facilities), outpatient, home health care, pharmacies, Emergency 

Medical Services (EMS), and public health.

In terms of information that either supports early allocation of doses to HCP or will pose a 

challenge, equity considerations support early vaccination of broadly defined HCP as there is 

high representation of racial minority groups in some healthcare settings, such as long-term 

care and home health care. As heard in the previous talk, all values-based allocation 

frameworks the WG reviewed included HCP in their earliest allocations. Feasibility 

considerations mostly support HCP as at least large healthcare systems have occupational 

health departments to facilitate vaccine clinics, and they may also have -800

C freezers. 

However, it will be more challenging to reach rural healthcare facilities, LTCF, small 

independent clinics, and home health care workers. Importantly, it will not be possible to assess 

the benefits or possible harms of any particular COVID vaccine until the clinical trials are 

complete.

Regarding Phase 1b essential workers, not including healthcare workers, the Cybersecurity and 

Infrastructure Security Agency (CISA) within the Department of Homeland Security (DHS) is 

responsible for creating a list of workers who are essential to continue critical infrastructure and 

maintain the services and functions Americans depend on daily. Their guidance acknowledges 

that workers who cannot perform their duties remotely and must work in close proximity to 

others should be prioritized for mitigation measures. It is also important to recognize that subcategories of essential workers may be prioritized differently in different jurisdictions depending 

upon local needs. The estimated population for this group, not including HCP, is 60 million 

people. Although not exhaustive, some examples include workers in industries such as food and 

agriculture, transportation, education, energy, water and wastewater, and law enforcement.

Although few specific surveillance systems for COVID-19 exist within critical industries, there 

are numerous examples of outbreaks affecting these workers. By July 2020, hundreds of 

outbreaks had been documented in meat and poultry processing plants affecting thousands of 

workers1

. Similarly, corrections and detention facilities’ residents and staff have been hard-hit2,3. 

In New York City (NYC), seroprevalence among correctional facility workers and fire department 

workers on the frontlines exceeded those of the general population4

 [1MMWR July 10, 2020 

https://www.cdc.gov/mmwr/volumes/69/wr/mm6927e2.htm?s_cid=mm6927e2_w; 2

UCLA 

COVID-19 Behind Bars Data Project https://law.ucla.edu/academics/ centers/criminal-justiceprogram/ucla-covid-19-behind-bars-data-project; 3

Hagan et al. MMWR – projected publication 

date August 7. Results of mass testing for SARS-CoV-2 in 16 prisons and jails—Six U.S. 

jurisdictions, April–May 2020;4

https://www.cdc.gov/vaccines/acip/meetings/ downloads/slides2020-07/COVID-06-Oliver-508.pdf].

There is a significant proportion of essential workers who also have high-risk medical conditions 

that range from about 30% of essential workers with obesity to about 2% with chronic kidney 

disease (CKD). It is estimated that more than a third of essential workers have a medical 

condition putting them at high-risk for severe COVID-19 disease. Essential industries may vary 

by the prevalence of high-risk medical conditions among their workers. For example, transit and 

postal workers have a slightly higher than average risk of cardiovascular disease (CVD) while 

workers in trucking have a disproportionate prevalence of obesity and diabetes1

. The racial and 

ethnic composition also varies among essential industries. Racial and ethnic minorities account 

for about 37% of US adults, but more than 50% of transit workers and utility workers. In fact, 

compared to all workers, Black workers are over-represented among frontline industries. 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

42

Hispanic workers are over-represented in industries such as trucking, warehousing, and building 

cleaning services. Despite performing work essential to the functioning of society, 23% of 

essential workers live in low-income families defined as income less than two times the poverty 

line. Moreover, 10% of essential workers have no health insurance. That reaches as high as 

30% in industries such as cleaning services. There is also overlap between essential workers 

and older adults. Approximately 16% of essential workers are either 65 or older themselves or 

live with someone who is 2 [1

https://www.cdc.gov/mmwr/volumes/69/wr/ mm6936a3.htm?s_ 

cid=mm6936a3_w; 2 Source: American Community Survey. CEPRs Analysis of American 

Community Survey, https://cepr.net/a-basic-demographic-profile-of-workers-in-frontlineindustries/].

The WG’s summary of the considerations for essential workers are that overall, equity 

considerations support early vaccination of essential workers as there is high representation of 

racial and ethnic minorities and many workers may be in low-income families or have no health 

insurance. Although all values-based frameworks the WG reviewed recognized essential 

workers for early vaccinations, they differed in their prioritization of specific industries. It is still 

largely unknown how essential workers value COVID-19 vaccination. In terms of feasibility, 

essential workers are generally mobile and vaccine points of dispensing may be deployed to 

work sites. Because essential industries vary by jurisdiction, states will likely have to make 

prioritization decisions which will exercise local flexibility. On the other hand, prioritization 

exercises will increase workload and create the potential for differences from state-to-state. 

Finally, the acceptance of COVID-19 vaccine among essential workers is not precisely known. 

Moving to the Phase 1b group of persons with high-risk medical conditions, focusing on adults 

with medical conditions at higher risk for severe COVID-19, the estimated population for this 

group is over 100 million adults in the US. This is a rough estimate and may change as 

evidence is gained about the conditions which confer risk. The current list of conditions includes: 

cancer, CKD, chronic obstructive pulmonary disease (COPD), immunocompromised state from 

solid organ transplant, obesity defined as body mass index (BMI) of 30 or greater, serious heart 

conditions (heart failure, coronary artery disease, or cardiomyopathies), sickle cell disease, type 

2 diabetes mellitus. The percentage of adults with selected medical conditions ranges from 

approximately 31% with obesity to 3% with CKD.

In terms of risk for COVID-19 disease, nearly 90% of hospitalized adults had at least one highrisk medical condition and over 60% have three or more1

. Obesity, CKD, diabetes, and 

hypertension are associated with hospitalization for COVID-192

. Among hospitalized COVID-19 

patients, the adjusted rate ratios for underlying medical conditions associated with death ranged 

from 1.19 for diabetes to 1.39 for immunosuppression3

 [1https://gis.cdc.gov/grasp/COVIDNet/ 

COVID19_5.html; 2

Ko et al. Clinical Infectious Diseases, ciaa1419, https://doi.org/10.1093/cid/

ciaa1419; 3Kim et al, Clinical Infectious Diseases, ciaa1012, https://doi.org/10.1093/

cid/ciaa1012].

The prevalence of selected underlying conditions varies by race and ethnicity. For example, the 

prevalence of diagnosed cancer, CKD, and CVD is either similar across all racial and ethnic 

groups or higher in whites. Whereas the prevalence of diabetes and obesity was highest among 

American Indians and Alaska Natives [National Center for Health Statistics, National Health 

Interview Survey, 2018. Estimates were not available for Hawaiian/other Pacific Islanders or for 

CKD among American Indian/Alaska Native populations].
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

43

In summary, the WG’s considerations for high-risk medical conditions are that equity may be 

challenged by early vaccination of adults with high-risk medical conditions because diagnosis of 

these conditions may require access to healthcare. All of the allocation frameworks that were 

reviewed support persons with high risk medical conditions as early phase vaccine recipients. 

Supporting feasibility of vaccination, persons with medical conditions are often connected with 

healthcare. On the other hand, the number of people in this group is greater than 100 million 

and likely will require some prioritization if vaccine supply is constrained. This will be difficult 

considering the high degree of overlap between conditions like obesity and diabetes. Moreover, 

assessing medical eligibility within the context of a mass vaccination clinic is logistically 

challenging. In terms of acceptability, this group has moderate influenza vaccine coverage, but it 

is not yet known how this group will view acceptability or value Phase 1 receipt of COVID-19 

vaccine.

Turning to Phase 1b adults ≥65 years of age, this group is estimated at approximately 53 million 

persons in the US. This accounts for approximately 16% of the U.S. population. Of note, 

approximately 3 million persons currently live in LTCF1

. In terms of COVID risk, adults 65 years 

and older represent 16% of COVID-19 cases but nearly 80% of COVID-19 deaths2

. Adults 65 

years and older have the highest cumulative rate of COVID-19 associated hospitalizations3

. 

Older age is the strongest independent risk factor for in-hospital death4

. Hispanic or Latino 

persons account for almost 18% of the total U.S. population, but only 8% of the population 65 

and older. Of this group, 77% are white and racial minority groups all comprise a smaller 

fraction of people 65 years of age and older compared to their proportion in the overall 

population. According to the National Health Interview Survey (NHIS) approximately 39% of 

adults 65 and older have a medical condition that puts them at high risk for severe COVID-19 

disease [1

United States Census Bureau https://www.census.gov/topics/population/olderaging.html https://www.cdc.gov/nchs/ fastats/nursing-home-care.htm; 2

https://www.cdc.gov/ 

covid-data-tracker/index.html# demographics; 3https://gis.cdc.gov/grasp/COVIDNet 

/COVID19_3.html; 4Kim et al, Clinical Infectious Diseases, ciaa1012, https://doi.org/10.1093/ 

cid/ciaa1012; https://www.census.gov/library/publications/2018/acs/acs-38.html].

When considering early vaccination of adults 65 and older, a challenge to equity is the underrepresentation of racial and ethnic minorities among older persons. Some allocation frameworks 

support the early vaccination of older persons, especially those living in congregate settings, 

while other frameworks suggest that older persons living at home and without underlying 

medical conditions should be vaccinated in Phase 2. In terms of feasibility, persons 65 and older 

usually have access to Medicare and a high proportion have a regular place they receive 

healthcare. However, if mass vaccination clinics are necessary, mobility and social distancing 

may be difficult for some in this age group. As for acceptability, older adults have moderate 

influenza vaccine coverage. However, it is not yet known how this group will view acceptability 

or value early vaccination with COVID-19 vaccine.

To recap, the WG has reviewed the worker considerations of three possible groups for Phase 

1b vaccine allocation. The WG has articulated some key unknowns, which hamper more 

detailed sequencing for these groups. First, there are multiple vaccine characteristics that are 

not yet known such as the magnitude and balance of benefits and potential risks; the storage, 

distribution, and handling for cold-chain requirements that have ramifications for 

implementation; and whether vaccine efficacy and immunogenicity will be different in younger 

versus older recipients. Another unknown regards whether the vaccine will be approved under 

an Emergency Use Authorization (EUA) or licensure and which populations may be covered. 
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

44

Finally, the number of doses that will be available at the time of approval and the rate of scaleup are unknown.

As for next steps, the WG will continue to build scientific understanding of the epidemiology of 

the Phase 1 groups, modeling the impact of various vaccination strategies, and interpretation of 

early clinical trials safety data and plans for post-marketing safety monitoring. The WG will 

prepare the EtR framework for vaccines in Phase 3 clinical trials, including preparing an equity 

domain, gathering evidence on the value and acceptability domains among others, GRADEing 

safety and efficacy from Phase 3 data as it becomes available, and preparing policy options for 

ACIP consideration. Dr. Dooling requested discussion and input on the two questions she posed 

earlier for ACIP’s consideration.

Discussion Points

If constrained vaccine supply necessitates sequencing of groups in Phase 1b, what are 

the most important information gaps we need to fill for ACIP to make sequencing 

recommendations?

 Be very clear about serious COVID infection and death and separating that as the outcome 

from COVID infection:

 For example, many essential workers in some groups who do not have chronic 

conditions or who are younger may have a very high likelihood of infection and a 

higher or lower likelihood of mortality. 

 For this particular question, it may not be possible to answer the impact on those 

with severe disease versus transmission. The reason this might be important is that 

there may be a greater focus on preventing severe morbidity and mortality in some 

populations but preventing transmission in other populations. 

 It is interesting that none of the paradigms specifically called out older adults or staff in 

LTCF facilities, given the evidence that was presented previously at another meeting about 

the importance of vaccinating staff around them. This is one group within those ≥65 years of 

age who might be an important subgroup to call out.

 It could be beneficial to better understand what percent of hotspots have been due to 

essential workers and perhaps focus on these workers:

 This could decrease transmission, morbidity, and mortality; increase societal and 

economic benefits; and address equity.

 Thinking about how large the pool of essential workers is, it might make sense to 

move essential workers in hotspots into Phase 1a. This might also address some of 

the concerns people have about making sure there is a priority for disadvantaged 

populations; using the SVI might have more impact. Getting 80 million doses in 

addition to the 20 million is going to de-prioritize essential workers in hotspots. 

 It is important to understand acceptability in each of the groups:

 Determine how to figure in the limited acceptance that some of these groups may 

have.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

45

 Perhaps some mathematical modeling could help to ascertain varied rates of 

acceptance of the vaccine, which will in turn impact distribution and administration.

 There appears to be overwhelming support for and wholehearted agreement with the 

principles of the frameworks presented and how consistent the WG’s proposed principles 

are with those:

 In terms of the exploration of the EtR, these principles for prioritizing groups should 

be used for allocation, distribution, and administration in order to get the vaccine to 

the prioritized groups and actually into them. 

 Perhaps V-SAFE, which will initially roll out among HCP, could be used among additional 

essential workers as well.

 Early on when there is constrained supply, it is going to be very difficult for state and local 

health immunization program directors to allocate the vaccine that they have control over to 

particular venues in terms of deciding which ones to go with first:

 Within Phase 1b, it could be beneficial to have as much differentiation and 

information as possible to rank them. Perhaps a ranked list of the smallest sub-group 

divisions possible would be helpful.

 The benefit-risk balance is unknown for all of the vaccines. For example, if the 

benefit-risk balance in adults over 65 looks quite different than in younger adults, that 

might influence the ordering and vice versa. If a benefit-risk balance is extremely 

favorable versus moderate, that also may influence the approach that might be taken 

to maximize the benefits and risks in any given population. This will depend upon the 

characteristics of the vaccines.

 In low-income areas, access to facilities that can provide the vaccine may be more 

challenging:

 Consider placing more emphasis on mobile van distribution to ensure vaccine 

access in disadvantaged populations

 In terms of prioritizing groups and the implementation process, consideration should be 

given up front to the importance of operationalizing access to second doses to ensure that 

the vaccines doses administered are effective.

 An important information gap is that it is unknown how the pediatric population fits into the 

equation, but it is likely to factor in since they will not be immunized, but certainly will 

interface with all of these groups of adults.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

46

Considering all the groups discussed, what is the correct balance of national guidance

and local flexibility?

 There must be some degree of local flexibility within the boundaries of the guidelines that 

that ACIP establishes, in part because this will be important in delivering vaccine to a 

number of the significant groups listed. While there has to be some degree of flexibility, the 

boundaries should be respected.

 One argument for greater national guidance is because it is at this level where there is the 

greatest transparency. Transparency is not always quite as good at the intermediate and 

local control levels.

 This is a delicate and important question in terms of the national conversation and guidance. 

The easier the guidance can be made to follow and implement, the better it will be. There 

likely will need to be some local flexibility, but the more similar and transparent guidance is 

across the country, the better the process will go.

 There seem to be some clear domains that should be at the national level. For instance, 

guidance on the benefit/risk for transmission, hospitalizations, and deaths can be 

transmitted nationally. Guidance for VE early on, interim, the entire population, and those 

over 75 years of age could be at the national level. However, it is at the local level that local 

public health officials will need to know whether they are a hotspot or not, and that will 

change over time. Local authorities will know the prevalence among various kinds of 

essential workers. For example, some areas have many meat packing facility essential 

workers and other areas do not have any. Those at the local level will know their delivery 

mechanisms, practical aspects of implementation, and perhaps the values of the population. 

There must be a balance between national guidelines and local flexibility.

 The idea that hotspot analyses can be used to make decisions about how to target vaccines 

is somewhat troubling given that hotspot analyses do not predict very far out and may not 

predict out past the second dose of vaccine if it is a 28-day vaccine that then takes another 

week to be effective. There may be other reasons to target hotspots, such as helping to 

ensure that people understand the risks. Nevertheless, it is important to be careful how this 

is communicated to state and local health departments so that it is not inappropriately 

suggested that these current vaccines would be a short-term tool for controlling outbreaks.

 The reality is that what is occurring at the local level has to drive the response for the 

community and local public health, so flexibility is critical.

 National guidance can provide high-level recommendations or principles that drive 

implementation, but the local level is where the implementation actually happens. 

Preserving the autonomy of local leaders who are critical in supporting implementation in 

their areas will be very important. Perhaps implementation metrics could be developed for 

accountability. For instance, one metric could focus on measuring equity in terms of 

distribution and administration. Think about the SVI as a tool for this rather than focusing on 

hotspots, which come and go and might not be predictable in sufficient time to get vaccine 

distributed in advance. Communities at risk are well-known independent of disease activity 

and should be advocated for as priority populations.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

47

 National guidance is very important in terms of the delicate issue of balance. There is 

currently an imbalance and it seems that much more national guidance is needed at this 

point. At the same time, operationalizing national guidance and allowing for flexibility at the 

local level are also important.

 This vaccine is unlikely to be used for hotspots as it will not be feasible given the way the 

vaccine needs to be stored, drawn up, and used. Flexibility for local planning seems to 

pertain more to whether the community has strawberry farms, meat packing plants, or 

something else. The idea is to keep workers safe who cannot work from home.

 Consideration also must be given to how vaccines will be distributed among states. It seems 

that disease prevalence and hotspots will be important considerations in terms of how many 

doses are delivered to states so that they can then use the flexibility needed to deliver to 

local communities.

 It is very clear that these first vaccines are not amenable to outbreak control. Therefore, it is 

not convincing that hotspot analysis would play a major role in decision-making. Part of the 

decision regarding allocation will be driven by the ACIP recommendations. In the absence of 

specific information about the vaccine and priority groups, it is difficult to say exactly how 

vaccine will be allocated. But as state and local health departments know, in order to do 

planning, CDC has given states the broad outlines of some scenarios that are thought to 

make sense in terms of prioritization as a starting point. Part of what CDC looks to ACIP for 

is to help the agency by making those very specific recommendations.

 While national guidance is important, there must be some local flexibility because there are 

likely to be marked differences in vaccine uptake even among those considered to be higher 

risk individuals. 

 While national guidance is important and necessary, it is important to be careful that the 

level of guidance is not too granular such that it bogs down or paralyzes vaccination 

campaigns because of complex decision-making, data gathering, and paperwork. It would 

be best for states and communities to plan how they are going to distribute and administer 

the vaccines such that the process is as efficient as it can be. This would need to be done 

before they are shipped to distribute and administer. Early planning will be most effective 

and efficient and too much oversight is not always the best choice.

 The AMA submitted a paper to the WG based on the AMA Code of Medical Ethics: 

Allocating Scare Vaccine Supplies in a Public Health Crisis. One of the topics that was 

raised in this document is distribution based on the geography of need and perhaps in some 

instances that might be preferable ethically to putting foundational values into play. The 

geography of need requires an approach that determines the number of vaccine doses 

provided based on identifying those communities where, based on the available evidence, 

access to vaccine supplies could reasonably be expected to have the greatest effect. Such 

decisions might take into account such factors as known emerging hotspots and structural 

factors that influence the risk and rate of transmission, such as population density, 

demographics, and living conditions. This approach is different from what is normally done, 

would require an infrastructure for data collection, and likely would demand new channels of 

communication and coordination. This would involve things that could only be accomplished 

by looking at this at a local level.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

48

Certification

Upon reviewing the foregoing version of the September 22, 2020 ACIP meeting minutes, Dr. 

Jose Romero, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

49

ACIP Membership Roster

Department of Health and Human Services 

Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

July 1, 2019 – December 31, 2020 

 

CHAIR

ROMERO, José R., MD, FAAP

Professor of Pediatrics

Horace C. Cabe Endowed Chair in Infectious Diseases Director, Pediatric Infectious Diseases 

Section

University of Arkansas for Medical Sciences and Arkansas Children's Hospital 

Director, Clinical Trials Research

Arkansas Children's Hospital Research Institute

Little Rock, AR

Term: 10/30/2018-06/30/2021

EXECUTIVE SECRETARY

COHN, Amanda, MD

Senior Advisor for Vaccines 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Atlanta, GA

MEMBERS

ATMAR, Robert L., MD

John S. Dunn Clinical Research Professor in Infectious Diseases

Departments of Medicine and Molecular Virology & Microbiology 

Baylor College of Medicine 

Chief, Infectious Diseases Service 

Ben Taub General Hospital, Harris Health System

Houston, TX

Term: 7/1/2016 – 6/30/2020

AULT, Kevin A., MD, FACOG, FIDSA 

Professor and Division Director

Department of Obstetrics and Gynecology

University of Kansas Medical Center

Kansas City, KS

Term: 10/26/2018 – 6/30/2022
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

50

BAHTA, Lynn, RN, MPH, CPH

Immunization Program Clinical Consultant

Infectious Disease, Epidemiology, Prevention & Control Division

Minnesota Department of Health

Saint Paul, Minnesota

Term: 7/1/2019 – 6/30/2023

BELL, Beth P., MD, MPH

Clinical Professor

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA

Term: 7/1/2019 – 6/30/2023

BERNSTEIN, Henry, DO, MHCM, FAAP

Professor of Pediatrics

Zucker School of Medicine at Hofstra/Northwell

Cohen Children’s Medical Center

New Hyde Park, NY

Term: 11/27/2017-06/30/2021

FREY, Sharon E., M.D.

Professor and Associate Director of Clinical Research

Clinical Director, Center for Vaccine Development

Division of Infectious Diseases, Allergy and Immunology

Saint Louis University Medical School

Saint Louis, MO

Term: 11/27/2017-06/30/2021

HUNTER, Paul, MD

Associate Professor of Family Medicine and Community Health

University of Wisconsin School of Medicine and Public Health

Associate Medical Director 

City of Milwaukee Health Department

Milwaukee, WI

Term: 7/1/2016 – 6/30/2020

LEE, Grace M., MD, MPH

Associate Chief Medical Officer for Practice Innovation

Lucile Packard Children’s Hospital

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA

Term: 7/1/2016 – 6/30/2020
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

51

MCNALLY, Veronica V., JD

President and CEO

Franny Strong Foundation

West Bloomfield, Michigan

Term: 10/31/2018 – 6/30/2022

POEHLING, Katherine A., MD, MPH

Professor of Pediatrics and Epidemiology and Prevention Director, Pediatric Population Health

Department of Pediatrics

Wake Forest School of Medicine

Winston-Salem, NC

Term: 7/1/2019 – 6/30/2023

SÁNCHEZ, Pablo J., M.D.

Professor of Pediatrics

The Ohio State University – Nationwide Children’s Hospital

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases

Director, Clinical & Translational Research (Neonatology)

Center for Perinatal Research

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio

Term: 7/1/2019 – 6/30/2023

SZILAGYI, Peter, MD, MPH 

Professor of Pediatrics

Executive Vice-Chair and Vice-Chair for Research

Department of Pediatrics 

University of California, Los Angeles (UCLA)

Los Angeles, California

Term: 7/1/2016 – 6/30/2020

TALBOT, Helen Keipp, MD

Associate Professor of Medicine Vanderbilt University

Nashville, TN

Term: 10/29/2018 – 6/30/2022
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

52

EX OFFICIO MEMBERS

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth

Senior Policy Advisor

Division of Quality, Evaluations and Health Outcomes

Children and Adults Health Programs Group

Center for Medicaid, CHIP and Survey & Certification

Centers for Medicare and Medicaid Services

Baltimore, MD

Food and Drug Administration (FDA)

FINK, Doran, MD, PhD

Deputy Director, Clinical, Division of Vaccines and Related Products Applications Office of 

Vaccines Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration

Silver Spring, MD

Health Resources and Services Administration (HRSA)

RUBIN, Mary, MD

Chief Medical Officer 

Division of Injury Compensation Programs

Rockville, MD

Indian Health Service (IHS)

WEISER, Thomas, MD, MPH

Medical Epidemiologist

Portland Area Indian Health Service

Portland, OR

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD CAPT,

US Public Health Service Director Division of Vaccines

Washington, DC 

National Institutes of Health (NIH)

BEIGEL, John, M.D.

Associate Director for Clinical Research

Division of Microbiology and Infectious Diseases

National Institute of Allergy and Infectious Diseases (NIAID) Bethesda, MD
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

53

LIAISON REPRESENTATIVES

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO

Associate Professor, Department of Family Medicine,

University of Michigan Medical School

Medical Director, Dominos Farms Family Medicine Ann Arbor, MI

American Academy of Pediatrics (AAP)

MALDONADO, Yvonne, MD

Senior Associate Dean for Faculty Development and Diversity

Professor of Pediatrics and Health Research and Policy

Chief, Division of Pediatric Infectious Diseases

Stanford University School of Medicine

Stanford, CA

American Academy of Pediatrics (AAP)

Red Book Editor 

KIMBERLIN, David, MD

Professor of Pediatrics

Division of Pediatric Infectious Diseases

The University of Alabama at Birmingham School of Medicine

Birmingham, AL

American Academy of Physician Assistants (AAPA)

LÉGER, Marie-Michèle, MPH, PA-C Senior Director, Clinical and Health Affairs

American Academy of Physician Assistants

Alexandria, VA

American College Health Association (ACHA)

CHAI, Thevy S, MD

Director of Medical Services

Campus Health Services

University of North Carolina at Chapel Hill

Chapel Hill, NC

American College Health Association (ACHA) (alternate)

MCMULLEN, Sharon, RN, MPH, FACHA

Assistant Vice President of Student & Campus Life for Health and Wellbeing

Cornell Health

Ithaca, NY
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

54

American College of Nurse Midwives (ACNM)

HAYES, Carol E., CNM, MN, MPH Lead Clinician

Clinical Quality Compliance and Management

Planned Parenthood Southeast 

Atlanta, GA

American College of Nurse Midwives (ACNM) (alternate)

MEHARRY, Pamela M., PHD, CNM

Midwifery Educator, Human Resources for Health

In partnership with University of Rwanda and University of Illinois, Chicago

American College of Obstetricians and Gynecologists (ACOG)

ECKERT, Linda O., MD, FACOG

Professor, Department of Obstetrics & Gynecology

Adjunct Professor, Department of Global Health

University of Washington

Seattle, WA

American College of Physicians (ACP)

GOLDMAN, Jason M. MD, FACP

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic

University, Boca Raton, Florida

Private Practice

Coral Springs, FL

American Geriatrics Society (AGS)

SCHMADER, Kenneth, MD

Professor of Medicine-Geriatrics

Geriatrics Division Chief

Duke University and Durham VA Medical Centers

Durham, NC

America’s Health Insurance Plans (AHIP)

GLUCKMAN, Robert A., MD, MACP

Chief Medical Officer, Providence Health Plans

Beaverton, OR

American Immunization Registry Association (AIRA)

COYLE, Rebecca, MSEd

Executive Director, AIRA

Washington, DC

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD

Adjunct Associate Professor of Medicine

Emory University School of Medicine

Atlanta, GA
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

55

American Nurses Association (ANA)

RITTLE, Charles (Chad), DNP, MPH, RN

Assistant Professor, Nursing Faculty

Chatham University, School of Health Sciences

Pittsburgh, PA

American Osteopathic Association (AOA)

GROGG, Stanley E., DO

Associate Dean/Professor of Pediatrics

Oklahoma State University-Center for Health Sciences

Tulsa, OK

American Pharmacists Association (APhA) FOSTER, Stephan L., PharmD CAPT (Ret) 

U.S.P.H.S.

Professor, College of Pharmacy

University of Tennessee Health Sciences Center

Memphis, TN

Association of Immunization Managers (AIM)

HOWELL, Molly, MPH Immunization Program Manager

North Dakota Department of Health

Bismarck, ND

Association for Prevention Teaching and Research (APTR)

McKINNEY, W. Paul, MD

Professor and Associate Dean

University of Louisville School of Public Health and Information Sciences

Louisville, KY

Association of State and Territorial Health Officials (ASTHO)

SHAH, Nirav D, MD, JD

Director

Maine Center for Disease Control and Prevention

Augusta, ME

Biotechnology Industry Organization (BIO)

ARTHUR, Phyllis A., MBA

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy

Washington, DC

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD State Epidemiologist

Office of Epidemiology, Food Protection and Immunization Idaho Department of Health and

Welfare

Boise, ID
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

56

Council of State and Territorial Epidemiologists (CSTE) (alternate)

LETT, Susan, MD, MPH

Medical Director, Immunization Program

Division of Epidemiology and Immunization

Massachusetts Department of Public Health

Boston, MA

Canadian National Advisory Committee on Immunization (NACI)

QUACH, Caroline, MD, MSc

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab

Montreal-CHUM

Montreal, Québec, Canada

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J, MD

Professor of Pediatrics

Molecular Virology and Microbiology

Baylor College of Medicine

Houston, TX

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD

Professor of Pediatrics

Boston University School of Medicine

Boston, MA

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD

Medical Director, Epidemiology

Orange County Health Care Agency

Santa Ana, CA

National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD

Health Officer and Chief, Communicable Disease Epidemiology and Immunization Section 

Public Health - Seattle and King County

Professor in Medicine, Division of Allergy and Infectious Diseases

University of Washington School of Medicine and School of Public Health

Seattle, WA

National Association of Pediatric Nurse Practitioners (NAPNAP)

STINCHFIELD, Patricia A., RN, MS, CPNP

Director, Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota

St. Paul, MN
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

57

National Foundation for Infectious Diseases (NFID)

SCHAFFNER, William, MD

Chairman, Department of Preventive Medicine

Vanderbilt University School of Medicine

Nashville, TN

National Foundation for Infectious Diseases (NFID) (alternate)

DALTON, Marla, PE, CAE

Executive Director & CEO

National Foundation for Infectious Diseases (NFID)

Bethesda, MD

National Medical Association (NMA)

WHITLEY-WILLIAMS, Patricia, MD

Professor and Chair

University of Medicine and Dentistry of New Jersey

Robert Wood Johnson Medical School 

New Brunswick, NJ

Pediatric Infectious Diseases Society (PIDS)

O’LEARY, Sean, MD, MPH

Associate Professor of Pediatrics

Pediatric Infectious Diseases

General Academic Pediatrics

Children’s Hospital Colorado

University of Colorado School of Medicine

Pediatric Infectious Diseases Society (PIDS) (alternate)

SAWYER, Mark H, MD

Professor of Clinical Pediatrics

University of California, San Diego School of Medicine

San Diego, CA

Pharmaceutical Research and Manufacturers of America (PhRMA)

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur

Swiftwater, PA

Society for Adolescent Health and Medicine (SAHM)

MIDDLEMAN, Amy B., MD, MSEd, MPH

Professor of Pediatrics

Chief, Section of Adolescent Medicine

University of Oklahoma Health Sciences Center

Oklahoma City, OK
Advisory Committee on Immunization Practices (ACIP) Summary Report September 22, 2020

58

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS

Chief Infection Prevention Officer & Hospital Epidemiologist

ChristianaCare

Wilmington, DE

Associate Professor of Medicine Sidney Kimmel Medical College at Thomas Jefferson 

University

Philadelphia, PA